Testicular Germ Cell TumorNCT02677727
Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
An observational study of Testicular Germ Cell Tumor, run by Costantine Albany at 3 sites in United States.
Trial summary
This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- EORTC QLQ-CIPN20
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2015to 17 Jun 2020
- 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 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are beign treated with cisplatin-based chemotherapy for testicular germ cell tumor
Who may be able to join
- 15 years of age or older at the time of informed consent
- Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
- Provide written informed consent and assent (if applicable).
- Ability to complete questionnaire(s) in English by themselves or with assistance.
- Willing to provide a 10 mL blood sample for future DNA testing
- Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy.
- Must agree to continued clinical follow-up at the study cancer center.
Who cannot join
- Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
- Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
- Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Mayo Clinic Department of Medical Oncology
Rochester, Minnesota, 55905
About this study
Official title: A Study of the Natural History of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.
Read the detailed description
Primary Objective:
To describe the incidence and characteristics of, and change in, chronic neuropathy symptoms related to cisplatin, using the EORTC CIPN-20 instrument
Procedures:
The EORTC QLQ-CIPN20 questionnaire will be completed on day one of each cycle of chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from the last dose of chemotherapy. Patients will be asked to complete the questionnaire in clinic during their routine visits.
As part of this study, a DNA blood sample will be collected and stored with the Indiana Biobank on Day 1 of Cycle 1.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- EORTC QLQ-CIPN20
- Keywords
- Cisplatin-based chemotherapy, Chemotherapy-induced peripheral neuropathy
- Medical subject headings
- Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-CIPN20Other
EORTC QLQ-CIPN20 is a 20-item chemotherapy-induced peripheral neuropathy-specific questionnaire which includes three scales assessing sensory (9 items: #31-36, 39, 40, 48), motor (8 items: #37, 38, 41-45, 49), and autonomic (3 items: #46, 47, 50) symptoms and functioning with each item measured on a 1-4 scale (1 - not at all; 4 - very much).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neuropathy
As measured by cumulative EORTC CIPN-20 scores
Measured: 18 months
Secondary outcomes (1)
Change in neuropathy
As measured by change in EORTC CIPN-20 scores
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start1 Jul 2015
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Costantine Albany
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor-investigator, Costantine Albany, Indiana University
- Investigators
- Costantine Albany, MD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677727
- Sponsor's protocol ID
- IUSCC-0502
- Other IDs
- 1412960547
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albany C, Dockter T, Wolfe E, Le-Rademacher J, Wagner-Johnston N, Einhorn L, Lafky JM, Smith E, Pachman D, Staff N, Ma C, Loprinzi CL, Costello BA. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer. 2021 Feb;29(2):833-840. doi: 10.1007/s00520-020-05543-5. Epub 2020 Jun 4.
PubMed 32500206
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Natural History of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT02677727
- Acronym / sponsor ID
- IUSCC-0502
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- Cisplatin-based chemotherapy, Chemotherapy-induced peripheral neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Costantine AlbanyUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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 prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.
Detailed description
Primary Objective:
To describe the incidence and characteristics of, and change in, chronic neuropathy symptoms related to cisplatin, using the EORTC CIPN-20 instrument
Procedures:
The EORTC QLQ-CIPN20 questionnaire will be completed on day one of each cycle of chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from the last dose of chemotherapy. Patients will be asked to complete the questionnaire in clinic during their routine visits.
As part of this study, a DNA blood sample will be collected and stored with the Indiana Biobank on Day 1 of Cycle 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are beign treated with cisplatin-based chemotherapy for testicular germ cell tumor
Key inclusion criteria (7 listed)
- 15 years of age or older at the time of informed consent
- Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
- Provide written informed consent and assent (if applicable).
- Ability to complete questionnaire(s) in English by themselves or with assistance.
- Willing to provide a 10 mL blood sample for future DNA testing
Key exclusion criteria (3 listed)
- Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
- Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
- Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
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 |
|---|---|---|
| EORTC QLQ-CIPN20EORTC QLQ-CIPN20 is a 20-item chemotherapy-induced peripheral neuropathy-specific questionnaire which includes three scales assessing sensory (9 items: #31-36, 39, 40, 48), motor (8 items: #37, 38, 41-45, 49), and autonomic (3 items: #46, 47, 50) symptoms and functioning with each item measured on a 1-4 scale (1 - not at all; 4 - very much). | Other | – |
Primary outcome
Incidence of neuropathy
Time frame: 18 months
As measured by cumulative EORTC CIPN-20 scores
1 secondary outcome
Change in neuropathy
Time frame: 18 months
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 22 Sep 2020.
- Derived from this study: PubMed 32500206Albany C, Dockter T, Wolfe E, Le-Rademacher J, Wagner-Johnston N, Einhorn L, Lafky JM, Smith E, Pachman D, Staff N, Ma C, Loprinzi CL, Costello BA. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer. 2021 Feb;29(2):833-840. doi: 10.1007/s00520-020-05543-5. Epub 2020 Jun 4.
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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.
Costantine Albany, MD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Germ Cell Tumor, run by Costantine Albany at 3 sites 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 7 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Incidence of neuropathy (time frame: 18 months). 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 NCT02677727, which also lists 1 linked publication.
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 22 Sep 2020.