Testicular NeoplasmNCT04531709
Financial Toxicity and Quality of Life in Patients With TGCT
An observational study of Testicular Neoplasm, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Neoplasm
- What is being tested?
- Comprehensive Score for financial toxicity (COST), Functional Assessment of Cancer Therapy: General (FACT-G) and EORTC QLQ C-30
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 4 Feb 2025
- Phase
- Observational
- 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
Study population: Patients diagnosed with testicular germ cell tumors TGCT, divided into non-seminomatous germ cell tumors (NSGCT) and seminomas; both of which are treated with a combination of surgery and chemotherapy or radiation depending on stage of disease.
Who may be able to join
- Age > 18 years of age
- Patients with histologically or clinically confirmed germ cell tumor.
- Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.
- Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
- Signed informed consent
Who cannot join
- Long-term survivors
- Patients undergoing active chemotherapy
- Patients who did not complete 1st line chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.
- Conditions
- Testicular Neoplasm
- Being tested
- Comprehensive Score for financial toxicity (COST), Functional Assessment of Cancer Therapy: General (FACT-G), EORTC QLQ C-30, EORTC QLQ-TC26.
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Score for financial toxicity (COST)Other
Measure indirect and direct health care cost that burden patients and their loved ones.
Functional Assessment of Cancer Therapy: General (FACT-G)Other
General quality of life instrument
EORTC QLQ C-30Other
Assess quality of life in cancer patients
EORTC QLQ-TC26.Other
To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Long-term survivors of TGCT | Not described Receives: Other: Comprehensive Score for financial toxicity (COST); Other: Functional Assessment of Cancer Therapy: General (FACT-G); Other: EORTC QLQ C-30; Other: EORTC QLQ-TC26. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
Measured: 5 years
Secondary outcomes (1)
Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Mar 2023
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Testicular NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepak Pruthi, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531709
- Sponsor's protocol ID
- CTMS 20-0061
- Other IDs
- HSC20200462E
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2020
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
PubMed 27716900Nigam M, Aschebrook-Kilfoy B, Shikanov S, Eggener S. Increasing incidence of testicular cancer in the United States and Europe between 1992 and 2009. World J Urol. 2015 May;33(5):623-31. doi: 10.1007/s00345-014-1361-y. Epub 2014 Jul 17.
PubMed 25030752Baird DC, Meyers GJ, Hu JS. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15;97(4):261-268.
PubMed 29671528Palumbo C, Mistretta FA, Mazzone E, Knipper S, Tian Z, Perrotte P, Antonelli A, Montorsi F, Shariat SF, Saad F, Simeone C, Briganti A, Lattouf JB, Karakiewicz PI. Contemporary Incidence and Mortality Rates in Patients With Testicular Germ Cell Tumors. Clin Genitourin Cancer. 2019 Oct;17(5):e1026-e1035. doi: 10.1016/j.clgc.2019.06.003. Epub 2019 Jun 13.
PubMed 31378580Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.
PubMed 21228314Sztankay M, Aaronson NK, Arraras JI, Basso U, Bumbasirevic U, Efficace F, Giesinger JM, Johnson CD, van Leeuwen M, Oberguggenberger AS, Sosnowski R, Young T, Holzner B; European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG). International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26. BMC Cancer. 2018 Nov 12;18(1):1104. doi: 10.1186/s12885-018-5036-8.
PubMed 30419889
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT04531709
- Acronym / sponsor ID
- CTMS 20-0061
- Conditions
- Testicular Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 28 Aug 2020 (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.
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term survivors of TGCT | – | Other: Comprehensive Score for financial toxicity (COST), Other: Functional Assessment of Cancer Therapy: General (FACT-G), Other: EORTC QLQ C-30, Other: EORTC QLQ-TC26. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with testicular germ cell tumors TGCT, divided into non-seminomatous germ cell tumors (NSGCT) and seminomas; both of which are treated with a combination of surgery and chemotherapy or radiation depending on stage of disease.
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Patients with histologically or clinically confirmed germ cell tumor.
- Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.
- Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
- Signed informed consent
Key exclusion criteria (3 listed)
- Long-term survivors
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 |
|---|---|---|
| Comprehensive Score for financial toxicity (COST)Measure indirect and direct health care cost that burden patients and their loved ones. | Other | Long-term survivors of TGCT |
| Functional Assessment of Cancer Therapy: General (FACT-G)General quality of life instrument | Other | Long-term survivors of TGCT |
| EORTC QLQ C-30Assess quality of life in cancer patients | Other | Long-term survivors of TGCT |
| EORTC QLQ-TC26.To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire. | Other | Long-term survivors of TGCT |
Primary outcome
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
Time frame: 5 years
1 secondary outcome
Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 27716900de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
- Results publication: PubMed 25030752Nigam M, Aschebrook-Kilfoy B, Shikanov S, Eggener S. Increasing incidence of testicular cancer in the United States and Europe between 1992 and 2009. World J Urol. 2015 May;33(5):623-31. doi: 10.1007/s00345-014-1361-y. Epub 2014 Jul 17.
- Results publication: PubMed 29671528Baird DC, Meyers GJ, Hu JS. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15;97(4):261-268.
- Results publication: PubMed 31378580Palumbo C, Mistretta FA, Mazzone E, Knipper S, Tian Z, Perrotte P, Antonelli A, Montorsi F, Shariat SF, Saad F, Simeone C, Briganti A, Lattouf JB, Karakiewicz PI. Contemporary Incidence and Mortality Rates in Patients With Testicular Germ Cell Tumors. Clin Genitourin Cancer. 2019 Oct;17(5):e1026-e1035. doi: 10.1016/j.clgc.2019.06.003. Epub 2019 Jun 13.
- Results publication: PubMed 21228314Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.
- Results publication: PubMed 30419889Sztankay M, Aaronson NK, Arraras JI, Basso U, Bumbasirevic U, Efficace F, Giesinger JM, Johnson CD, van Leeuwen M, Oberguggenberger AS, Sosnowski R, Young T, Holzner B; European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG). International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26. BMC Cancer. 2018 Nov 12;18(1):1104. doi: 10.1186/s12885-018-5036-8.
- Individual participant dataSharing planned: No
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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.
Deepak Pruthi, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Neoplasm, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 14 Jul 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531709, which also lists 6 linked publications.
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 14 Jul 2025.