Testicular Germ Cell TumorNCT00553371
Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer
An observational study of Testicular Germ Cell Tumor, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
RATIONALE: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care. PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- biomarker analysis and computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2006to not given
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic nonseminomatous germ cell tumor (NSGCT) at risk of developing late relapse of residual abnormality
- Royal Marsden Hospital stage II-IV disease
- Treatment for NSGCT completed within the past 5 to10 years
- No evidence of disease after completion of chemotherapy, as demonstrated by negative CT scans within the past 3 years
PATIENT CHARACTERISTICS:
- Willing to attend follow-up for five years
- No contraindication to CT imaging
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Robert A. Huddart, MD, 44-20-8661-3457, robert.huddart@icr.ac.uk
About this study
Official title: Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)
RATIONALE: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care.
PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer.
Read the detailed description
OBJECTIVES:
- To assess the frequency of relapse or recurrent abnormalities detected by CT scan in patients on long-term follow-up for metastatic nonseminomatous germ cell tumour (NSGCT).
- To assess the utility of CT scan-assessment in these patients.
- To assess the prognostic factors predictive of late relapse in NSGCT.
OUTLINE: This is a multicenter study.
Patients are screened by CT scan of the chest, abdomen, and pelvis for detectable abnormalities or indications of late relapse. Scans are classified as positive or negative, according to standard CT criteria, by a radiologist with expertise in testicular cancer imaging. Patients with negative scans are followed yearly by clinical examination and tumor marker assessment, and every 5 years by CT imaging. Additional follow-up is performed at the discretion of the attending physician. Patients with positive scans undergo confirmation of relapse, whenever possible, by surgical excision or biopsy and treatment is initiated according to best clinical practice. If the follow-up scan is equivocal, patients are advised to have a follow-up scan of the affected region in 6 months.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- biomarker analysis, computed tomography
- Keywords
- stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor
- Medical subject headings
- Testicular Germ Cell Tumor, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker analysisOther
computed tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
Secondary outcomes (3)
Rate of false positive abnormalities not due to NSGCT but due to benign process
Rate of relapse following initial CT scan
Number of abnormalities detected on second CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startApr 2006
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.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Robert A. Huddart, MD, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553371
- Sponsor's protocol ID
- CDR0000573199
- Other IDs
- ICR-RMH-NSGCT, EU-20770
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)
- ClinicalTrials.gov ID
- NCT00553371
- Acronym / sponsor ID
- CDR0000573199
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2006
- First posted
- 5 Nov 2007 (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: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care.
PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer.
Detailed description
OBJECTIVES:
- To assess the frequency of relapse or recurrent abnormalities detected by CT scan in patients on long-term follow-up for metastatic nonseminomatous germ cell tumour (NSGCT).
- To assess the utility of CT scan-assessment in these patients.
- To assess the prognostic factors predictive of late relapse in NSGCT.
OUTLINE: This is a multicenter study.
Patients are screened by CT scan of the chest, abdomen, and pelvis for detectable abnormalities or indications of late relapse. Scans are classified as positive or negative, according to standard CT criteria, by a radiologist with expertise in testicular cancer imaging. Patients with negative scans are followed yearly by clinical examination and tumor marker assessment, and every 5 years by CT imaging. Additional follow-up is performed at the discretion of the attending physician. Patients with positive scans undergo confirmation of relapse, whenever possible, by surgical excision or biopsy and treatment is initiated according to best clinical practice. If the follow-up scan is equivocal, patients are advised to have a follow-up scan of the affected region in 6 months.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| biomarker analysis | Other | – |
| computed tomography | Procedure or surgery | – |
Primary outcome
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
3 secondary outcomes
Rate of false positive abnormalities not due to NSGCT but due to benign process
Rate of relapse following initial CT scan
Number of abnormalities detected on second CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Robert A. Huddart, MD study chair
Royal Marsden NHS Foundation Trust
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 Germ Cell Tumor, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan. 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 26 Aug 2013.