Testicular Germ Cell TumorNCT00003800
Diagnostic Study of Patients With Stage I Testicular Cancer
A study testing immunohistochemistry staining method, laboratory biomarker analysis and radionuclide imaging in people with Testicular Germ Cell Tumor, run by Eastern Cooperative Oncology Group at 12 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer. PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks. Read more about this study
- Who is it for?
- Ages 15 to 120 years, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- immunohistochemistry staining method, laboratory biomarker analysis and radionuclide imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Nov 1999to Dec 2004
- 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 15 to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinical stage I nonseminomatous germ cell tumor of the testis
- Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks
- AFP and HCG normal or decreasing after orchiectomy at a rate consistent with known half lives
- Pathology blocks and radiologic studies available
- No metastatic disease on physical exam or chest or abdominal/pelvic CT
- No pure seminoma (unless associated with elevated AFP at diagnosis)
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior malignancy including prior primary testicular cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
CCOP - Columbus
Columbus, Ohio, 43206
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
CCOP - Scott and White Hospital
Temple, Texas, 76508
About this study
Official title: Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.
PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.
Read the detailed description
OBJECTIVES:
- Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis.
- Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients.
OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active surveillance as management of their disease. The choice of treatment is determined by the physician and the patient. Patients with pathologically positive resected lymph nodes may undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion.
All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline and then at various times after surgery to identify pathologic stage II disease. The timing of these studies depends on the stage of disease and/or type of disease management.
Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2, every 6 months during years 3-5, and annually thereafter.
Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5, and annually thereafter.
Patients who do not undergo RPLND are followed monthly during year 1, every other month during year 2, every 6 months during years 3-5, and annually thereafter.
PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- immunohistochemistry staining method, laboratory biomarker analysis, radionuclide imaging
- Keywords
- stage I malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, testicular embryonal carcinoma, testicular choriocarcinoma, testicular teratoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor, testicular yolk sac tumor and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma
- Medical subject headings
- Testicular Germ Cell Tumor, Testicular Neoplasms, Teratoma, Testicular, Endodermal Sinus Tumor, Teratoma, Carcinoma, Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
radionuclide imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laboratory/CT evaluation | No intervention | Observation following orchiectomy Receives: Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: radionuclide imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of regional or metastatic spread
Patients with putative stage A non-seminomatous germ cell tumors are assessed at baseline using chest xray and blood markers. They are then followed monthly during year 1, every 2 months during year 2, twice a year during years 3-5, and annually thereafter.
Measured: observed at least annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start16 Nov 1999
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard S. Foster, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003800
- Sponsor's protocol ID
- CDR0000066944
- Other IDs
- U10CA021115, ECOG-8897
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT00003800
- Acronym / sponsor ID
- CDR0000066944
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- stage I malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, testicular embryonal carcinoma, testicular choriocarcinoma, testicular teratoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Nov 1999 (actual)
- Primary completion
- Dec 2004 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.
PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.
Detailed description
OBJECTIVES:
- Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis.
- Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients.
OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active surveillance as management of their disease. The choice of treatment is determined by the physician and the patient. Patients with pathologically positive resected lymph nodes may undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion.
All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline and then at various times after surgery to identify pathologic stage II disease. The timing of these studies depends on the stage of disease and/or type of disease management.
Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2, every 6 months during years 3-5, and annually thereafter.
Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5, and annually thereafter.
Patients who do not undergo RPLND are followed monthly during year 1, every other month during year 2, every 6 months during years 3-5, and annually thereafter.
PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory/CT evaluation | No intervention | Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: radionuclide imagingObservation following orchiectomy |
Who may qualify
- Ages
- 15 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| immunohistochemistry staining method | Other | Laboratory/CT evaluation |
| laboratory biomarker analysis | Other | Laboratory/CT evaluation |
| radionuclide imaging | Procedure or surgery | Laboratory/CT evaluation |
Primary outcome
Evidence of regional or metastatic spread
Time frame: observed at least annually
Patients with putative stage A non-seminomatous germ cell tumors are assessed at baseline using chest xray and blood markers. They are then followed monthly during year 1, every 2 months during year 2, twice a year during years 3-5, and annually thereafter.
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 Jun 2023.
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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.
Richard S. Foster, MD study chair
Indiana University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunohistochemistry staining method, laboratory biomarker analysis and radionuclide imaging in people with Testicular Germ Cell Tumor, run by Eastern Cooperative Oncology Group at 12 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?
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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Evidence of regional or metastatic spread (time frame: observed at least annually). 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 22 Jun 2023.