Germ Cell TumorHGT-QoLNCT05889585
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
A study testing quality of life questionnaire in people with Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Germ Cell Tumor
- What is being tested?
- quality of life questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, 94805
Natacha NAOUN, MD, +33 (0)1 42 11 42 11 ext. 22 09, natacha.naoun@gustaveroussy.fr
About this study
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
- Germ Cell Tumor
- Being tested
- quality of life questionnaire
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireOther
EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3
| Study group | Role | What they receive |
|---|---|---|
| high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years. | Other | Men with a histologically-confirmed (or high level serum tumor marker-based) diagnosis of germ-cell tumor, treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at Gustave Roussy and relapse-free after a minimum of 3 years. Receives: Other: quality of life questionnaire |
| Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years | Other | Men with a histologically confirmed (or high level serum tumor marker-based) stage I germ cell tumor, treated by orchidectomy only and no evidence of relapse after a minimum of 3 years. Receives: Other: quality of life questionnaire |
| Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years. | Other | Men with a histologically confirmed (or high level serum tumor marker-based) germ cell tumor and good or intermediate prognosis metastatic disease according to the International Germ-Cell Cancer Collaborative Group (IGCCCG), treated by first line cisplatin-based chemotherapy (and surgery of residual masses if needed), with no evidence of relapse after a minimum of 3 years. Receives: Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.
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.
Measured: Day 1
Secondary outcomes (5)
Compare late side effects between the three groups.
Measured: Day 1
Compare correlated morbidities between the three groups.
Measured: Day 1
Compare fatigue measured by the MFI-20 scale between the three groups.
Measured: Day 1
Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.
Measured: Day 1
Compare current social and professional situation between the three groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start31 May 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889585
- Sponsor's protocol ID
- 2021-A00855-36
- Other IDs
- 2020/3139
- Acronym
- HGT-QoL
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05889585
- Acronym / sponsor ID
- HGT-QoL / 2021-A00855-36
- Conditions
- Germ Cell Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years. | Other | Other: quality of life questionnaireMen with a histologically-confirmed (or high level serum tumor marker-based) diagnosis of germ-cell tumor, treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at Gustave Roussy and relapse-free after a minimum of 3 years. |
| Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years | Other | Other: quality of life questionnaireMen with a histologically confirmed (or high level serum tumor marker-based) stage I germ cell tumor, treated by orchidectomy only and no evidence of relapse after a minimum of 3 years. |
| Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years. | Other | Other: quality of life questionnaireMen with a histologically confirmed (or high level serum tumor marker-based) germ cell tumor and good or intermediate prognosis metastatic disease according to the International Germ-Cell Cancer Collaborative Group (IGCCCG), treated by first line cisplatin-based chemotherapy (and surgery of residual masses if needed), with no evidence of relapse after a minimum of 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life questionnaireEORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3 | Other | Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years., Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years, high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years. |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life questionnaire in people with Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha NAOUN, MD (+ 33 (0)1 42 11 42 11 ext. 20 09, natacha.naoun@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.