Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05889585

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life Questionnaire

Other

EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3

Primary outcomes

  1. Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.

    Time frame: Day 1

    To compare the quality of life in long-term survivors of germ cell cancers after high-dose chemotherapy and autologous stem cell transplant with a group of coetaneous patients treated by orchidectomy only for localized testicular tumor and a group of patients of the same age treated with first line cisplatin-based chemotherapy for good or intermediate prognosis advanced germ cell tumor.

Secondary outcomes

  1. Compare late side effects between the three groups.

    Time frame: Day 1

  2. Compare correlated morbidities between the three groups.

    Time frame: Day 1

  3. Compare fatigue measured by the MFI-20 scale between the three groups.

    Time frame: Day 1

  4. Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.

    Time frame: Day 1

  5. Compare current social and professional situation between the three groups.

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Karim Fizazi, MD, Prof.

CONTACT

[email protected]

+ 33 (0)1 42 11 43 17

Natacha NAOUN, MD

CONTACT

[email protected]

+ 33 (0)1 42 11 42 11 ext. 20 09

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: HGT-QoL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.