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Clinical Trials
NCT00959023

Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

21000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-06-30

Brief Summary

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RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited risk of prostate cancer.

Detailed Description

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OBJECTIVES:

* To find genes that predispose to prostate cancer (using genetic linkage and other molecular biology techniques).
* To determine if genes that predispose to prostate cancer are associated with disease and treatment parameters.
* To determine if genes that predispose to prostate cancer are associated with environmental factors.
* To estimate the percentage of prostate cancer patients who have a positive family history of the disease.
* To estimate the relative risk of developing prostate cancer in a currently unaffected member of a prostate cancer family.
* To ascertain whether relatives of prostate cancer patients are at increased risk of developing cancers other than prostate cancer.
* To build up a large blood and tumor (both fresh and preserved) bank from patients with prostate cancer to identify prostate cancer predisposition gene(s), determine the prevalence and penetrance of prostate cancer predisposition genes in prostate cancer patients, correlate changes in prostate cancer predisposition gene(s) with disease and treatment parameters by matching with clinical data from clinical databases already held as part of the medical record on these patients, and correlate changes in prostate cancer predisposition gene(s) with environmental factors collected by questionnaire from these patients.
* To use the blood and tumor bank for marker studies (DNA, RNA, serum, plasma, protein, and other molecules) to define the role of these markers in disease prediction and progression.
* To develop microarrays from prostate cancers to determine their genetic profile and correlate this with prostate cancer genetic predisposition genes.
* To collect tissue from other unaffected and affected members of the family in cases where a genetic alteration is found, in order to ascertain whether this alteration is associated with disease risk.
* To collect tissue samples from unaffected family members who show an interest in taking part in the study.

OUTLINE: Patients are assessed by a family history and epidemiology questionnaire and undergo a medical record review.

Patients and relatives with prostate cancer may undergo blood sample collection for genetic analysis of prostate cancer predisposition genes and measurement of markers of associations with genetic changes associated with prostate cancer. Blood and tumor samples are stored for future studies.

Conditions

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Prostate Cancer

Keywords

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stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

* Diagnosis of prostate cancer meeting any of the following criteria:

* Attending prostate clinics at The Royal Marsden NHS Foundation Trust

* Any age at diagnosis
* Not attending prostate clinics at The Royal Marsden NHS Foundation Trust, meeting 1 of the following criteria:

* No older than 60 years at diagnosis
* Diagnosis in two relatives where one is ≤ 65 years at diagnosis
* At any age in a cluster with 3 or more cases
* Any unaffected male relatives of men who are already taking part in the study

PATIENT CHARACTERISTICS:

* Able to understand the information sheet and give informed consent
* No man who is too ill to take part

PRIOR CONCURRENT THERAPY:

* Not specified

Eligible Sex

MALE

Accepts Healthy Volunteers

Principal Investigators

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Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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William Harvey Hospital

Ashford-Kent, England, United Kingdom

Site Status RECRUITING

Tameside General Hospital

Ashton-under-Lyne, England, United Kingdom

Site Status RECRUITING

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, United Kingdom

Site Status RECRUITING

North Devon District Hospital

Barnstaple, England, United Kingdom

Site Status RECRUITING

Furness General Hospital

Barrow in Furness, England, United Kingdom

Site Status RECRUITING

Basildon University Hospital

Basildon, England, United Kingdom

Site Status RECRUITING

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Site Status RECRUITING

Royal United Hospital

Bath, England, United Kingdom

Site Status RECRUITING

Primrose Centre at Bedford Hospitals NHS Trust

Bedford, England, United Kingdom

Site Status RECRUITING

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status RECRUITING

City Hospital - Birmingham

Birmingham, England, United Kingdom

Site Status RECRUITING

Good Hope Hospital

Birmingham, England, United Kingdom

Site Status RECRUITING

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Site Status RECRUITING

Royal Blackburn Hospital

Blackburn, England, United Kingdom

Site Status RECRUITING

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status RECRUITING

Pilgrim Hospital

Boston, England, United Kingdom

Site Status RECRUITING

Royal Bournemouth Hospital

Bournemouth, England, United Kingdom

Site Status RECRUITING

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status RECRUITING

Southmead Hospital

Bristol, England, United Kingdom

Site Status RECRUITING

Frenchay Hospital

Bristol, England, United Kingdom

Site Status RECRUITING

Bristol Royal Infirmary

Bristol, England, United Kingdom

Site Status RECRUITING

Broomfield Hospital

Broomfield, England, United Kingdom

Site Status RECRUITING

Burnley General Hospital

Burnley, England, United Kingdom

Site Status RECRUITING

Queen's Hospital

Burton-on-Trent, England, United Kingdom

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status RECRUITING

Kent and Canterbury Hospital

Canterbury, England, United Kingdom

Site Status RECRUITING

St. Helier Hospital

Carshalton, England, United Kingdom

Site Status RECRUITING

Countess of Chester Hospital

Chester, England, United Kingdom

Site Status RECRUITING

Colchester General Hospital

Colchester, England, United Kingdom

Site Status RECRUITING

Castle Hill Hospital

Cottingham, England, United Kingdom

Site Status RECRUITING

Walsgrave Hospital

Coventry, England, United Kingdom

Site Status RECRUITING

Mid Cheshire Hospitals Trust- Leighton Hopsital

Crewe, England, United Kingdom

Site Status RECRUITING

Mayday University Hospital

Croydon, England, United Kingdom

Site Status RECRUITING

Darent Valley Hospital

Dartford Kent, England, United Kingdom

Site Status RECRUITING

Derbyshire Royal Infirmary

Derby, England, United Kingdom

Site Status RECRUITING

Royal Derby Hospital

Derby, England, United Kingdom

Site Status RECRUITING

Dorset County Hospital

Dorchester, England, United Kingdom

Site Status RECRUITING

Russells Hall Hospital

Dudley, England, United Kingdom

Site Status RECRUITING

Eastbourne District General Hospital

Eastbourne, England, United Kingdom

Site Status RECRUITING

Birmingham Women's Hospital

Edgbaston, England, United Kingdom

Site Status RECRUITING

Epsom General Hospital

Epsom, Surrey, England, United Kingdom

Site Status RECRUITING

Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

Site Status RECRUITING

Royal Bolton Hospital

Farnworth, England, United Kingdom

Site Status RECRUITING

Frimley Park Hospital

Frimley, England, United Kingdom

Site Status RECRUITING

Grantham and District Hospital

Grantham, Lincolnshire, England, United Kingdom

Site Status RECRUITING

Diana Princess of Wales Hospital

Grimsby, England, United Kingdom

Site Status RECRUITING

Harrogate District Hospital

Harrogate, England, United Kingdom

Site Status RECRUITING

Wycombe General Hospital

High Wycombe, England, United Kingdom

Site Status RECRUITING

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

Site Status RECRUITING

Ipswich Hospital

Ipswich, England, United Kingdom

Site Status RECRUITING

Kidderminster Hospital

Kidderminster Worcestershire, England, United Kingdom

Site Status RECRUITING

Royal Albert Edward Infirmary

Lancanshire, England, United Kingdom

Site Status RECRUITING

Royal Lancaster Infirmary

Lancaster, England, United Kingdom

Site Status RECRUITING

Leeds General Infirmary

Leeds, England, United Kingdom

Site Status RECRUITING

Cookridge Hospital

Leeds, England, United Kingdom

Site Status RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status RECRUITING

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status RECRUITING

Leicester General Hospital

Leicester, England, United Kingdom

Site Status RECRUITING

Lincoln County Hospital

Lincoln, England, United Kingdom

Site Status RECRUITING