Diagnostic Study of Patients With Stage I Testicular Cancer

NCT00003800 | Completed

• 3 other identifiers: CDR0000066944U10CA021115ECOG-8897
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 12

Brief 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.

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; testicular yolk sac tumor and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma

Outcome Measures

Primary Outcomes (1)

• 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.

  observed at least annually

Study Arms (1)

Laboratory/CT evaluation

NO INTERVENTION

Observation following orchiectomy

Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: radionuclide imaging

Interventions

immunohistochemistry staining method OTHER

Laboratory/CT evaluation

laboratory biomarker analysis OTHER

Laboratory/CT evaluation

radionuclide imaging PROCEDURE

Laboratory/CT evaluation

Eligibility Criteria

• Age: 15 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

MeSH Terms

Conditions

Testicular Germ Cell Tumor; Testicular Neoplasms; Teratoma, Testicular; Endodermal Sinus Tumor; Teratoma; Carcinoma, Embryonal

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Mesonephroma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Richard S. Foster, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 16, 1999
• Primary Completion: December 1, 2004
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (12)