Actively Recruiting
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
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-10-18
180
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3e�3d 18 years at diagnosis
- Treated between 1990 and 2015
- Histologically confirmed diagnosis of germ cell tumor (or high level serum tumor marker-based)
- Treated for relapse with high-dose chemotherapy with autologous transplant at Gustave Roussy and relapse-free
- Or treated by orchiectomy only with no evidence of relapse after at least 3 years
- Or good or intermediate prognosis metastatic disease treated by first line cisplatin-based chemotherapy at Gustave Roussy, with no evidence of relapse
- Ability to comply with the protocol procedures
- Affiliated to a social security system or beneficiary of the same
- Signed written informed consent prior to any study procedure
You will not qualify if you...
- Diagnosis of second malignancy
- Any serious or unstable illness, or medical, social, or psychological condition that could affect safety, compliance, or study participation
- Under guardianship or deprived of liberty by judicial or administrative decision
- Incapable of giving informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
N
Natacha NAOUN, MD
CONTACT
K
Karim Fizazi, MD, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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