Informations générales (source: ClinicalTrials.gov)
Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients (ONCOPRO)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2018
janvier 2028
29 juin 2024
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in
G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric
acids during digestion. It is also important for the regulation of cell growth of the
gastric mucosal.
In a healthy person, progastrin is not detectable in the peripheral blood. However,
progastrin is abnormally released in the blood of patients with different cancers
(colorectal, gastric, ovarian, breast, cervix uterus, melanoma...) The gene GAST coding
for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The
activation of this oncogenic pathway is an early event in cancer development.
Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human
solid tumors and is a central mechanism in cancer biology that induces cellular
proliferation, blocking of differentiation leading to primary tumor growth and metastasis
formation.
Progastrin measured in the peripheral blood of patients on treatments, could be a new
powerful marker for diagnosis and prognosis at different stages.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de Gynécologie de l'hôpital de la Croix-Rousse - Lyon - France | Marion CORTET, MD | Contact (sur clinicalTrials) | |||
| Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST - Bron - France | Francois DUCRAY, MD | Contact (sur clinicalTrials) | |||
| Service de Pneumologie du Groupement Hospitalier Est - Lyon - France | Michael DURUISSEAUX, MD | Contact (sur clinicalTrials) | |||
| Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud - Pierre-Bénite - France | Marion CHAUVENET, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie médicale du Centre hospitalier Lyon Sud - Pierre-Bénite - France | Benoit YOU, MD | Contact (sur clinicalTrials) | |||
| Service d'Urologie de l'hôpital Lyon Sud - Pierre-Bénite - France | Philippe PAPAREL, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de Chirurgie de l'hôpital Lyon Sud - Pierre-Bénite - France | Olivier GLEHEN, MD | Contact (sur clinicalTrials) | |||
| Service de Dermatologie de l'hôpital Lyon Sud - Pierre-Bénite - France | Stephane DALLE, MD | Contact (sur clinicalTrials) | |||
| Service de Gynécologie de l'hôpital Lyon Sud - Pierre-Bénite - France | Pierre Adrien BOLZE, MD | Contact (sur clinicalTrials) | |||
| Service de Gynécologie du Groupement Hospitalier Est - Lyon - France | Christophe SAJOUS, MD | Contact (sur clinicalTrials) | |||
| Service de Pneumologie de l'hôpital de la Croix-Rousse - Lyon - France | Gilles DEVOUASSOUX, MD | Contact (sur clinicalTrials) | |||
| Service de Pneumologie de l'Hôpital Lyon Sud - Pierre-Bénite - France | Sebastien COURAUD, MD | Contact (sur clinicalTrials) | |||
| Service d'Hématologie de l'Hôpital Lyon Sud - Pierre-Bénite - France | Lionel KARLIN, MD | Contact (sur clinicalTrials) | |||
| Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse - Lyon - France | Marielle GUILLET, MD | Contact (sur clinicalTrials) | |||
| Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot - Lyon - France | Thomas WALTER, MD | Contact (sur clinicalTrials) | |||
| Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse - Lyon - France | Amandine BRUYAS, MD | Contact (sur clinicalTrials) | |||
| Service d'Urologie de l'Hôpital E. Herriot - Lyon - France | Lionel BADET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- Histologically and/or cytologically documented (documentation obtained before or
after diagnostic surgical procedure when clinical suspicion is strong), cancers for
the following cohorts:
o Breast carcinomas
o Gastric carcinomas
o Renal carcinomas
o Prostate carcinomas
o Lung carcinomas: NSCLC and SCLC
o Hepatocellular carcinomas
o Colorectal carcinomas
- Head and neck carcinomas
- Thyroid cancer
- Pancreatic carcinomas
- Ovarian adenocarcinomas
- Glioblastoma
- Endometrial adenocarcinomas
- Bladder carcinoma
- Superficial Oesophago-gastric carcinomas
- Diffuse Large B-cell Lymphomas
- Patient older than 18 years.
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
Specific inclusion criteria for curative treatment strategy cancer patients:
- Indication of a treatment strategy with curative intent (surgery; radiotherapy;
chemotherapy; hormonotherapy; targeted agents...)
- Patient naïve of anticancer treatments for the considered cancer
- A prior anti-cancer treatment is allowed if this treatment was performed with
curative intent, and if it did not include systemic chemotherapy, and if a complete
remission ≥ 6 months was observed in between the end of treatment and relapse.
Previous local treatments for superficial lesions are allowed without any time
restriction (for example among others, intravesical treatment for superficial
bladder cancer lesions).
Specific inclusion criteria for non-curative treatment strategy cancer patients:
- Indication of a treatment strategy with no curative intent (radiotherapy;
chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery,
...)
- Patient naïve of anticancer treatments in non-curative setting (except for
metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).
The following tumor type specific inclusion criteria must be met in addition to the
inclusion criteria listed above:
Breast carcinomas
• All cohorts:
- Invasive breast ductal carcinoma, or
- Invasive breast lobular carcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant
chemotherapy and/or anti-hormone treatment
Gastric carcinomas
- All cohorts:
o Intestinal-type adenocarcinoma, or
o Diffuse cell type adenocarcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery with/without neo-adjuvant treatment,
with/without adjuvant treatment
Renal carcinomas • All cohorts:
- Any histology of renal cancer is accepted (non-clear cell renal cancer could be
included)
- A pathology proof of renal cell carcinoma is not necessarily provided if patients
present typical radiologic characteristics of renal cancer on imaging
• Curative intent treatment patients cohort:
- Planned to be treated with partial or total nephrectomy
Prostate carcinomas
- Curative intent treatment patients cohort:
o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or
Gleason >= 4+3 and/or PSA >= 20 and/or N+
o Planned to be treated with radical prostatectomy or radiotherapy (potentially
associated with androgen deprivation therapy). Brachytherapy and/or focused
ultrasounds are not allowed.
- Non-curative intent treatment patients cohort:
- Patients with metastatic castration resistant prostate cancer (mCRPC) defined
by validated criteria of EAU, planned to be treated with doceteaxel or
cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide).
Patients have to be naïve of treatment for the castration resistant mCRPC.
Patients that previously received docetaxel or a 1st or 2nd generation
hormonotherapy for their hormone-sensitive prostate cancer in metastatic
setting can be included.
Lung carcinomas treated by immunotherapy :
• Non-curative intent patients cohort:
o NSCLC stage IV according to 8th TNM classification planned to be treated with
immunotherapy, with/ without chemotherapy
Lung carcinomas excluding those treated with immunotherapy:
- Curative intent treatment patients cohort:
o NSCLC histology only
o Stage I-II according to 8th TNM classification
o Stage IIIA-B according to 8th TNM classification
o Planned to be treated with radical treatment (surgery or radiotherapy with/without
concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant
treatment
- Non-curative intent patients cohort:
- NSCLC or SCLC stage IV according to 8th TNM classification planned to be
treated with a first line of chemotherapy, with/without associated treatments
except immunotherapy (radiotherapy, targeted therapies...). Immunotherapy can
be administrated for the subsequent lines of treatment.
Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if
patients present typical radiologic characteristics of hepatocellular carcinoma on
imaging
- Absence or chronic hepatic encephalopathy, absence of refractory ascites
- Curative intent treatment patients cohort:
- Indication of a treatment strategy with curative intent, except liver
transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to
3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).
• Non-curative intent patients cohort:
- Indication of a treatment strategy with no curative intent: transarterial
intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or
monoclonal antibodies) or immune therapy.
Colorectal carcinomas
• Curative intent treatment patients cohort:
o Lieberkühn adenocarcinoma associated with metastases planned to be treated with
peri-operative chemotherapy +/- targeted agent and interval surgery
Head and neck carcinomas
- All cohorts
o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx,
larynx
- Curative intent treatment patients cohort:
o Planned to be treated with a radical treatment (surgery and/or radiotherapy
potentially associated with concurrent chemotherapy) with/without
neo-adjuvant/adjuvant chemotherapy.
- Non-curative intent treatment patients cohort:
o De novo metastatic or metastatic/loco-regional relapse planned to be treated with
chemotherapy and/or immunotherapy
Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated,
poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment
is indicated (Iodine treatment will be discussed after surgery. In the case the
histological result does not confirm a high risk thyroid cancer, patient will be
withdrawn from the study. In the same way, if a iodine treatment is not recommended after
surgery, patient will be withdrawn from the study. In both cases, patient will be
replaced).
Pancreatic carcinomas
• Curative intent patients cohort:
o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery
with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or
radiotherapy
Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort:
o 1st platinum-sensitive relapse
- High or low grade epithelial adenocarcinomas or carcinosarcoma
- Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/-
interval debulking surgery
Glioblastoma • Curative intent patients cohort:
o Planned to be treated with surgical resection, followed by adjuvant temozolomide and
radiotherapy
Endometrial adenocarcinomas
- Non-curative intent patients cohort:
o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell,
undifferentiated carcinoma and carcinosarcoma) cancers
o Planned to be treated with non-curative systemic treatment for metastatic or
advanced disease
Bladder carcinoma
- Transitional cell carcinoma • Curative intent treatment patients:
- Patients with localized muscle invasive bladder cancer (>=PT2)
- Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or
immunotherapy or a combination of chemotherapy and immunotherapy
Superficial Oesophago-gastric cancer • Curative intent patients cohort:
o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of
Stage T1 planned to be treated by endoscopic surgery
Diffuse Large B-Cell Lymphoma (DLBCL)
• Curative intent patients cohort:
o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide,
Hydroxyadriamycine, Oncovin, Prednisone)
after diagnostic surgical procedure when clinical suspicion is strong), cancers for
the following cohorts:
o Breast carcinomas
o Gastric carcinomas
o Renal carcinomas
o Prostate carcinomas
o Lung carcinomas: NSCLC and SCLC
o Hepatocellular carcinomas
o Colorectal carcinomas
- Head and neck carcinomas
- Thyroid cancer
- Pancreatic carcinomas
- Ovarian adenocarcinomas
- Glioblastoma
- Endometrial adenocarcinomas
- Bladder carcinoma
- Superficial Oesophago-gastric carcinomas
- Diffuse Large B-cell Lymphomas
- Patient older than 18 years.
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
Specific inclusion criteria for curative treatment strategy cancer patients:
- Indication of a treatment strategy with curative intent (surgery; radiotherapy;
chemotherapy; hormonotherapy; targeted agents...)
- Patient naïve of anticancer treatments for the considered cancer
- A prior anti-cancer treatment is allowed if this treatment was performed with
curative intent, and if it did not include systemic chemotherapy, and if a complete
remission ≥ 6 months was observed in between the end of treatment and relapse.
Previous local treatments for superficial lesions are allowed without any time
restriction (for example among others, intravesical treatment for superficial
bladder cancer lesions).
Specific inclusion criteria for non-curative treatment strategy cancer patients:
- Indication of a treatment strategy with no curative intent (radiotherapy;
chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery,
...)
- Patient naïve of anticancer treatments in non-curative setting (except for
metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).
The following tumor type specific inclusion criteria must be met in addition to the
inclusion criteria listed above:
Breast carcinomas
• All cohorts:
- Invasive breast ductal carcinoma, or
- Invasive breast lobular carcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant
chemotherapy and/or anti-hormone treatment
Gastric carcinomas
- All cohorts:
o Intestinal-type adenocarcinoma, or
o Diffuse cell type adenocarcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery with/without neo-adjuvant treatment,
with/without adjuvant treatment
Renal carcinomas • All cohorts:
- Any histology of renal cancer is accepted (non-clear cell renal cancer could be
included)
- A pathology proof of renal cell carcinoma is not necessarily provided if patients
present typical radiologic characteristics of renal cancer on imaging
• Curative intent treatment patients cohort:
- Planned to be treated with partial or total nephrectomy
Prostate carcinomas
- Curative intent treatment patients cohort:
o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or
Gleason >= 4+3 and/or PSA >= 20 and/or N+
o Planned to be treated with radical prostatectomy or radiotherapy (potentially
associated with androgen deprivation therapy). Brachytherapy and/or focused
ultrasounds are not allowed.
- Non-curative intent treatment patients cohort:
- Patients with metastatic castration resistant prostate cancer (mCRPC) defined
by validated criteria of EAU, planned to be treated with doceteaxel or
cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide).
Patients have to be naïve of treatment for the castration resistant mCRPC.
Patients that previously received docetaxel or a 1st or 2nd generation
hormonotherapy for their hormone-sensitive prostate cancer in metastatic
setting can be included.
Lung carcinomas treated by immunotherapy :
• Non-curative intent patients cohort:
o NSCLC stage IV according to 8th TNM classification planned to be treated with
immunotherapy, with/ without chemotherapy
Lung carcinomas excluding those treated with immunotherapy:
- Curative intent treatment patients cohort:
o NSCLC histology only
o Stage I-II according to 8th TNM classification
o Stage IIIA-B according to 8th TNM classification
o Planned to be treated with radical treatment (surgery or radiotherapy with/without
concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant
treatment
- Non-curative intent patients cohort:
- NSCLC or SCLC stage IV according to 8th TNM classification planned to be
treated with a first line of chemotherapy, with/without associated treatments
except immunotherapy (radiotherapy, targeted therapies...). Immunotherapy can
be administrated for the subsequent lines of treatment.
Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if
patients present typical radiologic characteristics of hepatocellular carcinoma on
imaging
- Absence or chronic hepatic encephalopathy, absence of refractory ascites
- Curative intent treatment patients cohort:
- Indication of a treatment strategy with curative intent, except liver
transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to
3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).
• Non-curative intent patients cohort:
- Indication of a treatment strategy with no curative intent: transarterial
intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or
monoclonal antibodies) or immune therapy.
Colorectal carcinomas
• Curative intent treatment patients cohort:
o Lieberkühn adenocarcinoma associated with metastases planned to be treated with
peri-operative chemotherapy +/- targeted agent and interval surgery
Head and neck carcinomas
- All cohorts
o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx,
larynx
- Curative intent treatment patients cohort:
o Planned to be treated with a radical treatment (surgery and/or radiotherapy
potentially associated with concurrent chemotherapy) with/without
neo-adjuvant/adjuvant chemotherapy.
- Non-curative intent treatment patients cohort:
o De novo metastatic or metastatic/loco-regional relapse planned to be treated with
chemotherapy and/or immunotherapy
Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated,
poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment
is indicated (Iodine treatment will be discussed after surgery. In the case the
histological result does not confirm a high risk thyroid cancer, patient will be
withdrawn from the study. In the same way, if a iodine treatment is not recommended after
surgery, patient will be withdrawn from the study. In both cases, patient will be
replaced).
Pancreatic carcinomas
• Curative intent patients cohort:
o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery
with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or
radiotherapy
Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort:
o 1st platinum-sensitive relapse
- High or low grade epithelial adenocarcinomas or carcinosarcoma
- Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/-
interval debulking surgery
Glioblastoma • Curative intent patients cohort:
o Planned to be treated with surgical resection, followed by adjuvant temozolomide and
radiotherapy
Endometrial adenocarcinomas
- Non-curative intent patients cohort:
o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell,
undifferentiated carcinoma and carcinosarcoma) cancers
o Planned to be treated with non-curative systemic treatment for metastatic or
advanced disease
Bladder carcinoma
- Transitional cell carcinoma • Curative intent treatment patients:
- Patients with localized muscle invasive bladder cancer (>=PT2)
- Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or
immunotherapy or a combination of chemotherapy and immunotherapy
Superficial Oesophago-gastric cancer • Curative intent patients cohort:
o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of
Stage T1 planned to be treated by endoscopic surgery
Diffuse Large B-Cell Lymphoma (DLBCL)
• Curative intent patients cohort:
o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide,
Hydroxyadriamycine, Oncovin, Prednisone)