NCT00045045

Brief Summary

RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer. PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 18, 2013

Status Verified

September 1, 2002

First QC Date

September 6, 2002

Last Update Submit

December 17, 2013

Conditions

Keywords

stage I malignant testicular germ cell tumortesticular choriocarcinomatesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and seminomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and yolk sac tumortesticular embryonal carcinoma and seminomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinomatesticular teratomatesticular yolk sac tumor and teratoma with seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumor

Interventions

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen * Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis * Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin) * High-risk disease PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No evidence of active inflammatory or infective diseases * No other disease or prior malignancy that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics * No more than 8 weeks since prior orchidectomy Other * No prior positron emission tomography scans

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

Sponsors & Collaborators

Study Sites (8)

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Guy's and St. Thomas' Hospitals NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

Location

Meyerstein Institute of Oncology at University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, 5O14OYG, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

  • Huddart RA, O'Doherty MJ, Padhani A, Rustin GJ, Mead GM, Joffe JK, Vasey P, Harland SJ, Logue J, Daugaard G, Hain SF, Kirk SJ, MacKewn JE, Stenning SP; NCRI Testis Tumour Clinical Study Group. 18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. J Clin Oncol. 2007 Jul 20;25(21):3090-5. doi: 10.1200/JCO.2006.09.3831.

MeSH Terms

Conditions

Testicular Germ Cell TumorTesticular NeoplasmsCarcinoma, EmbryonalSeminomaTeratomaEndodermal Sinus TumorTeratoma, Testicular

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeGerminomaMesonephroma

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Robert A. Huddart, MD

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Study Completion

July 1, 2007

Last Updated

December 18, 2013

Record last verified: 2002-09

Locations