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

Launched by GUSTAVE ROUSSY, CANCER CAMPUS, GRAND PARIS · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into the long-term effects of high-dose chemotherapy and stem cell transplants on men who have survived germ cell tumors. Germ cell tumors are a type of cancer that affects the cells that produce sperm or eggs, and they are most commonly diagnosed in younger men. The study aims to understand how these treatments impact survivors' quality of life, including any physical and emotional side effects they may experience years after their treatment. This information is particularly important because many of these patients can live for decades after their diagnosis.

To be eligible for the trial, participants need to be at least 18 years old and must have been treated for their germ cell tumor between 1990 and 2015. They should have received high-dose chemotherapy and a stem cell transplant, or they might have undergone surgery without any signs of cancer returning for at least three years. Participants will be asked to share their experiences, helping doctors better understand the long-term challenges faced by survivors. It’s important to know that men with other serious health issues or a second cancer diagnosis cannot participate. This research is a crucial step in improving the care and support for those who have battled germ cell tumors.

Gender

MALE

Eligibility criteria

• 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.
• Exclusion Criteria:
• • 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.