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

Recruiting now · Not applicable

Conditions studied: Germ Cell Tumor

In brief

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.

Key facts

Study ID

NCT05889585

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

180

Starts

2023-05-31

Expected to finish

2025-05-01

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gustave Roussy — Villejuif, France (enrolling)

Full record on ClinicalTrials.gov

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