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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

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

Recruiting
18 years and older
Male
Phase N/A

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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.

Eligibility

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.

Study details
    Germ Cell Tumor

NCT05889585

Gustave Roussy, Cancer Campus, Grand Paris

27 January 2024

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