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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: quality of life questionnaire.
- Who it may be relevant to
- Registry conditions: Germ Cell Tumor. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other quality of life questionnaire
EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3
Primary outcome measures
- Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire. [Time frame: Day 1]
Secondary outcome measures (5)
- Compare late side effects between the three groups. [Time frame: Day 1]
- Compare correlated morbidities between the three groups. [Time frame: Day 1]
- Compare fatigue measured by the MFI-20 scale between the three groups. [Time frame: Day 1]
- Compare symptoms of post-traumatic stress measured by the IES scale between the three groups. [Time frame: Day 1]
- Compare current social and professional situation between the three groups. [Time frame: Day 1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Gustave Roussy — Villejuif
Identifiers
NCT: NCT05889585 · 2021-A00855-36 · 2020/3139