Clinical trial NCT00959023: Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer
Official title: UK Genetic Prostate Cancer Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-14
Enrollment: 21000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Prostate cancer (PC) predisposition (PCP) genes
Secondary outcomes:
measure: Association of PCP genes with disease and treatment parameters
measure: Association of PCP with environmental factors
measure: Family history of PC
measure: Relative risk of developing PC
measure: Increased risk relatives of PC patients are to develop cancers other than PC
measure: Markers of PC that are associated with PCP genes
measure: Specific tumor genetic profile correlated with PCP genes
Other outcomes:
Locations:
city: Ashford-Kent
country: United Kingdom
facility: William Harvey Hospital
state: England
city: Ashton-Under-Lyne
country: United Kingdom
facility: Tameside General Hospital
state: England
city: Aylesbury-Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Barnstaple
country: United Kingdom
facility: North Devon District Hospital
state: England
city: Barrow in Furness
country: United Kingdom
facility: Furness General Hospital
state: England
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Bedford
country: United Kingdom
facility: Primrose Centre at Bedford Hospitals NHS Trust
state: England
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Birmingham
country: United Kingdom
facility: Good Hope Hospital
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
state: England
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: England
city: Brighton
country: United Kingdom
facility: Sussex Cancer Centre at Royal Sussex County Hospital
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: England
city: Broomfield
country: United Kingdom
facility: Broomfield Hospital
state: England
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
state: England
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Carshalton
country: United Kingdom
facility: St. Helier Hospital
state: England
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: England
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: England
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: England
city: Coventry
country: United Kingdom
facility: Walsgrave Hospital
state: England
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals Trust- Leighton Hopsital
state: England
city: Croydon
country: United Kingdom
facility: Mayday University Hospital
state: England
city: Dartford Kent
country: United Kingdom
facility: Darent Valley Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: England
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: England
city: Edgbaston
country: United Kingdom
facility: Birmingham Women's Hospital
state: England
city: Epsom, Surrey
country: United Kingdom
facility: Epsom General Hospital
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: Farnworth
country: United Kingdom
facility: Royal Bolton Hospital
state: England
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: England
city: Grantham, Lincolnshire
country: United Kingdom
facility: Grantham and District Hospital
state: England
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hospital
state: England
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: England
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
state: England
city: Hull
country: United Kingdom
facility: Princess Royal Hospital at Hull and East Yorkshire NHS Trust
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Kidderminster Worcestershire
country: United Kingdom
facility: Kidderminster Hospital
state: England
city: Lancanshire
country: United Kingdom
facility: Royal Albert Edward Infirmary
state: England
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: England
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
city: London
country: United Kingdom
facility: Whipps Cross Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: England
city: London
country: United Kingdom
facility: Middlesex Hospital
state: England
city: London
country: United Kingdom
facility: St. Mary's Hospital
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trust
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Nottinghamshire
country: United Kingdom
facility: Kings Mill Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: England
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
state: England
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: England
city: Peterborough
country: United Kingdom
facility: Peterborough Hospitals Trust
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Poole Dorset
country: United Kingdom
facility: Dorset Cancer Centre
state: England
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre at Royal Preston Hospital
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Redditch, Worcestershire
country: United Kingdom
facility: Alexandra Healthcare NHS
state: England
city: Romford
country: United Kingdom
facility: Queens Hospital
state: England
city: Saint Leonards-on-Sea
country: United Kingdom
facility: Conquest Hospital
state: England
city: Salford
country: United Kingdom
facility: Hope Hospital
state: England
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: England
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: England
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: England
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: England
city: Slough, Berkshire
country: United Kingdom
facility: Wexham Park Hospital
state: England
city: Solihull
country: United Kingdom
facility: Solihull Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Southport
country: United Kingdom
facility: Southport and Formby District General Hospital
state: England
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
state: England
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: England
city: Stirling
country: United Kingdom
facility: Stirling Royal Infirmary
state: England
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: England
city: Surrey
country: United Kingdom
facility: Kingston Hospital
state: England
city: Surrey
country: United Kingdom
facility: East Surrey Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Swindon
country: United Kingdom
facility: Great Western Hospital
state: England
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital
state: England
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: Warwick
country: United Kingdom
facility: Warwick Hospital
state: England
city: West Bromwich
country: United Kingdom
facility: Sandwell General Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: England
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: York
country: United Kingdom
facility: Cancer Care Centre at York Hospital
state: England
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust Incorporating Belvoir Park Hospital
state: Northern Ireland
city: Downpatrick
country: United Kingdom
facility: Downe Hospital
state: Northern Ireland
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
state: Northern Ireland
city: Portadown, Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Scotland
city: Falkirk
country: United Kingdom
facility: Falkirk and District Royal Infirmary
state: Scotland
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
state: Scotland
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Newport Gwent
country: United Kingdom
facility: Royal Gwent Hospital
state: Wales
city: Rhyl, Denbighshire
country: United Kingdom
facility: Glan Clwyd Hospital
state: Wales
city: Swansea
country: United Kingdom
facility: Singleton Hospital
state: Wales
city: Morecambe
country: United Kingdom
facility: Queen Victoria Hospital
city: Peterborough
country: United Kingdom
facility: Edith Cavell Hospital
city: Shoreham-by-Sea
country: United Kingdom
facility: Southlands Hospital
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci
role: PRINCIPAL_INVESTIGATOR
References: