Understanding long-term effects on quality of life in survivors of germ cell tumors treated with high-dose chemotherapy
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
This study is trying to see how surviving germ cell tumors and high-dose chemotherapy affects the long-term quality of life for patients, especially those diagnosed before 40.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT05889585 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term side effects and quality of life in patients who have survived germ cell tumors after receiving high-dose chemotherapy and autologous stem cell transplant. It aims to gather data on the physical and emotional consequences faced by these survivors, particularly since many are diagnosed before the age of 40 and may live several decades post-treatment. By utilizing quality of life questionnaires, the study seeks to provide insights that can help clinicians better support these patients. This research is particularly significant as there is currently no available data on this topic in France.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who were treated for germ cell tumors at Gustave Roussy between 1990 and 2015 and are currently relapse-free.
Not a fit: Patients with a diagnosis of a second malignancy or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of long-term health impacts on germ cell tumor survivors, leading to improved patient care and support.
How similar studies have performed: While this specific approach may be novel in France, similar studies in other regions have successfully highlighted the long-term effects of cancer treatments on survivors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Villejuif
- Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Natacha NAOUN, MD
- Email: natacha.naoun@gustaveroussy.fr
- Phone: + 33 (0)1 42 11 42 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.