Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated w… (NCT05889585) | Clinical Trial Compass
RecruitingNot Applicable
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
France180 participantsStarted 2023-05-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.