Informations générales (source: ClinicalTrials.gov)
Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated with High-dose Chemotherapy and Autologous Stem Cell Transplant
Interventional
N/A
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2023
mai 2025
11 septembre 2025
Intensified chemotherapy is an effective treatment in 30-70% of patients with refractory
germ cell tumor. Since most cases are diagnosed before the age of 40, survivors can
expect to live another 30 to 50 years after being successfully treated. Long-term side
effects and physical and emotional consequences can therefore have a significant impact
on daily life. To date, no data of this type is available in France. This study will help
clinicians better understand the long-term consequences for relapsed patients receiving
high-dose chemotherapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Natacha NAOUN | 14/06/2024 08:36:46 | Contacter | ||
Critères
Homme
Inclusion Criteria:
- Age ≥ 18 years at diagnosis
- Treated between 1990 and 2015
- Histologically confirmed diagnosis of germ cell tumor (or high level serum tumor
marker-based) and:
Treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at
Gustave Roussy and relapse-free.
Or Treated by orchiectomy only and no evidence of relapse after a minimum of 3 years.
Or Good or intermediate prognosis metastatic disease according to the IGCCCG, treated by
first line cisplatin-based chemotherapy at Gustave Roussy (and surgery of residual masses
if needed), with no evidence of relapse.
- Ability to comply with the protocol procedures
- Patient affiliated to a social security system or beneficiary of the same. 6-Who
have signed a written informed consent form prior to any study specific procedure.
- Age ≥ 18 years at diagnosis
- Treated between 1990 and 2015
- Histologically confirmed diagnosis of germ cell tumor (or high level serum tumor
marker-based) and:
Treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at
Gustave Roussy and relapse-free.
Or Treated by orchiectomy only and no evidence of relapse after a minimum of 3 years.
Or Good or intermediate prognosis metastatic disease according to the IGCCCG, treated by
first line cisplatin-based chemotherapy at Gustave Roussy (and surgery of residual masses
if needed), with no evidence of relapse.
- Ability to comply with the protocol procedures
- Patient affiliated to a social security system or beneficiary of the same. 6-Who
have signed a written informed consent form prior to any study specific procedure.
- Diagnosis of second malignancy
- Any other serious or unstable illness, or medical, social, or psychological
condition, that could jeopardize the safety of the subject and/or his compliance
with study procedures, or may interfere with the subject's participation in the
study or evaluation of the study results.
- Patient under guardianship or deprived of his/her liberty by a judicial or
administrative decision, or incapable of giving his/her consent.