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

Sponsor
Institute of Cancer Research, United Kingdom (Other)
Overall Status
Unknown status
CT.gov ID
NCT00959023
Collaborator
(none)
21,000
135
155.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis
  • Other: medical chart review
  • Other: questionnaire administration

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
21000 participants
Official Title:
UK Genetic Prostate Cancer Study
Study Start Date :
Jun 1, 1993

Outcome Measures

Primary Outcome Measures

  1. Prostate cancer (PC) predisposition (PCP) genes []

Secondary Outcome Measures

  1. Association of PCP genes with disease and treatment parameters []

  2. Association of PCP with environmental factors []

  3. Family history of PC []

  4. Relative risk of developing PC []

  5. Increased risk relatives of PC patients are to develop cancers other than PC []

  6. Markers of PC that are associated with PCP genes []

  7. Specific tumor genetic profile correlated with PCP genes []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 William Harvey Hospital Ashford-Kent England United Kingdom TN24 0LZ
2 Tameside General Hospital Ashton-Under-Lyne England United Kingdom OL6 9RW
3 Stoke Mandeville Hospital Aylesbury-Buckinghamshire England United Kingdom HP21 8AL
4 North Devon District Hospital Barnstaple England United Kingdom EX31 4JB
5 Furness General Hospital Barrow in Furness England United Kingdom LA14 4LF
6 Basildon University Hospital Basildon England United Kingdom SS16 5NL
7 Basingstoke and North Hampshire NHS Foundation Trust Basingstoke England United Kingdom RG24 9NA
8 Royal United Hospital Bath England United Kingdom BA1 3NG
9 Primrose Centre at Bedford Hospitals NHS Trust Bedford England United Kingdom MK42 9DJ
10 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Birmingham England United Kingdom B15 2TH
11 City Hospital - Birmingham Birmingham England United Kingdom B18 7QH
12 Good Hope Hospital Birmingham England United Kingdom B75 7RR
13 Birmingham Heartlands Hospital Birmingham England United Kingdom B9 5SS
14 Royal Blackburn Hospital Blackburn England United Kingdom BB2 3 HH
15 Blackpool Victoria Hospital Blackpool England United Kingdom FY3 8NR
16 Pilgrim Hospital Boston England United Kingdom PE21 9QT
17 Royal Bournemouth Hospital Bournemouth England United Kingdom BH7 7DW
18 Sussex Cancer Centre at Royal Sussex County Hospital Brighton England United Kingdom BN2 5BE
19 Southmead Hospital Bristol England United Kingdom BS10 5NB
20 Frenchay Hospital Bristol England United Kingdom BS16 1LE
21 Bristol Royal Infirmary Bristol England United Kingdom BS2 8HW
22 Broomfield Hospital Broomfield England United Kingdom CM1 7ET
23 Burnley General Hospital Burnley England United Kingdom BB10 2PQ
24 Queen's Hospital Burton-upon-Trent England United Kingdom DE13 0RB
25 Addenbrooke's Hospital Cambridge England United Kingdom CB2 2QQ
26 Kent and Canterbury Hospital Canterbury England United Kingdom CT1 3NG
27 St. Helier Hospital Carshalton England United Kingdom SM5 1AA
28 Countess of Chester Hospital Chester England United Kingdom CH2 1UL
29 Colchester General Hospital Colchester England United Kingdom CO4 5JL
30 Castle Hill Hospital Cottingham England United Kingdom HU16 5JQ
31 Walsgrave Hospital Coventry England United Kingdom CV2 2DX
32 Mid Cheshire Hospitals Trust- Leighton Hopsital Crewe England United Kingdom CW1 4QJ
33 Mayday University Hospital Croydon England United Kingdom
34 Darent Valley Hospital Dartford Kent England United Kingdom DA2 8DA
35 Derbyshire Royal Infirmary Derby England United Kingdom DE1 2QY
36 Royal Derby Hospital Derby England United Kingdom DE22 3NE
37 Dorset County Hospital Dorchester England United Kingdom DT1 2JY
38 Russells Hall Hospital Dudley England United Kingdom DY1 2HQ
39 Eastbourne District General Hospital Eastbourne England United Kingdom BN21 2UD
40 Birmingham Women's Hospital Edgbaston England United Kingdom B15 2TG
41 Epsom General Hospital Epsom, Surrey England United Kingdom KT18 7EG
42 Royal Devon and Exeter Hospital Exeter England United Kingdom EX2 5DW
43 Royal Bolton Hospital Farnworth England United Kingdom BL4 0JR
44 Frimley Park Hospital Frimley England United Kingdom GU16 7UJ
45 Grantham and District Hospital Grantham, Lincolnshire England United Kingdom NG31 8DG
46 Diana Princess of Wales Hospital Grimsby England United Kingdom DN33 2BA
47 Harrogate District Hospital Harrogate England United Kingdom HG2 7SX
48 Wycombe General Hospital High Wycombe England United Kingdom
49 Princess Royal Hospital at Hull and East Yorkshire NHS Trust Hull England United Kingdom HU8 9HE
50 Ipswich Hospital Ipswich England United Kingdom IP4 5PD
51 Kidderminster Hospital Kidderminster Worcestershire England United Kingdom DY11 6RJ
52 Royal Albert Edward Infirmary Lancanshire England United Kingdom WN1 2NN
53 Royal Lancaster Infirmary Lancaster England United Kingdom LA1 4RP
54 Leeds General Infirmary Leeds England United Kingdom LS1 3EX
55 Cookridge Hospital Leeds England United Kingdom LS16 6QB
56 Leeds Cancer Centre at St. James's University Hospital Leeds England United Kingdom LS9 7TF
57 Leicester Royal Infirmary Leicester England United Kingdom LE1 5WW
58 Leicester General Hospital Leicester England United Kingdom LE5 4PW
59 Lincoln County Hospital Lincoln England United Kingdom LN2 5QY
60 Royal Liverpool University Hospital Liverpool England United Kingdom L7 8XP
61 Royal London Hospital London England United Kingdom E1 1BB
62 Whipps Cross Hospital London England United Kingdom E11 1NR
63 Saint Bartholomew's Hospital London England United Kingdom EC1A 7BE
64 Guy's Hospital London England United Kingdom SE1 9RT
65 Hammersmith Hospital London England United Kingdom W12 OHS
66 Middlesex Hospital London England United Kingdom W1T 3AA
67 St. Mary's Hospital London England United Kingdom W2 1NY
68 Charing Cross Hospital London England United Kingdom W6 8RF
69 Macclesfield District General Hospital Macclesfield England United Kingdom SK10 3BL
70 Maidstone Hospital Maidstone England United Kingdom ME16 9QQ
71 Christie Hospital Manchester England United Kingdom M20 4BX
72 Clatterbridge Centre for Oncology Merseyside England United Kingdom CH63 4JY
73 James Cook University Hospital Middlesbrough England United Kingdom TS4 3BW
74 Milton Keynes General Hospital Milton Keynes England United Kingdom MK6 5LD
75 Newcastle Upon Tyne Hospitals NHS Trust Newcastle-Upon-Tyne England United Kingdom NE7 7DN
76 Mount Vernon Cancer Centre at Mount Vernon Hospital Northwood England United Kingdom HA6 2RN
77 Norfolk and Norwich University Hospital Norwich England United Kingdom NR4 7UY
78 Kings Mill Hospital Nottinghamshire England United Kingdom NG17 4JL
79 Nottingham City Hospital Nottingham England United Kingdom NG5 1PB
80 George Eliot Hospital Nuneaton England United Kingdom CV10 7DJ
81 Churchill Hospital Oxford England United Kingdom OX3 7LJ
82 Peterborough Hospitals Trust Peterborough England United Kingdom PE3 6DA
83 Derriford Hospital Plymouth England United Kingdom PL6 8DH
84 Dorset Cancer Centre Poole Dorset England United Kingdom BH15 2JB
85 Rosemere Cancer Centre at Royal Preston Hospital Preston England United Kingdom PR2 9HT
86 Berkshire Cancer Centre at Royal Berkshire Hospital Reading England United Kingdom RG1 5AN
87 Alexandra Healthcare NHS Redditch, Worcestershire England United Kingdom B98 7UB
88 Queens Hospital Romford England United Kingdom RM3 0BE
89 Conquest Hospital Saint Leonards-on-Sea England United Kingdom TN37 7RD
90 Hope Hospital Salford England United Kingdom M6 8HD
91 Salisbury District Hospital Salisbury England United Kingdom SP2 8BJ
92 Scarborough General Hospital Scarborough England United Kingdom YO12 6QL
93 Scunthorpe General Hospital Scunthorpe England United Kingdom DN15 7BH
94 Royal Shrewsbury Hospital Shrewsbury England United Kingdom SY3 8XQ
95 Wexham Park Hospital Slough, Berkshire England United Kingdom SL2 4HL
96 Solihull Hospital Solihull England United Kingdom B91 2JL
97 Southampton General Hospital Southampton England United Kingdom SO16 6YD
98 Southport and Formby District General Hospital Southport England United Kingdom PR8 6PN
99 Staffordshire General Hospital Stafford England United Kingdom ST16 3SA
100 Lister Hospital Stevenage England United Kingdom SG1 4AB
101 Stirling Royal Infirmary Stirling England United Kingdom FK8 2AU
102 Stepping Hill Hospital Stockport England United Kingdom SK2 7JE
103 Kingston Hospital Surrey England United Kingdom KT2 7QB
104 East Surrey Hospital Surrey England United Kingdom RH1 5RH
105 Royal Marsden - Surrey Sutton England United Kingdom SM2 5PT
106 Great Western Hospital Swindon England United Kingdom SN3 6BB
107 Taunton and Somerset Hospital Taunton England United Kingdom TA1 5DA
108 Torbay Hospital Torquay England United Kingdom TQ2 7AA
109 Hillingdon Hospital Uxbridge England United Kingdom UB8 3NN
110 Warwick Hospital Warwick England United Kingdom CV34 5BW
111 Sandwell General Hospital West Bromwich England United Kingdom B71 4HJ
112 Southend University Hospital NHS Foundation Trust Westcliff-On-Sea England United Kingdom SS0 0RY
113 New Cross Hospital Wolverhampton England United Kingdom WV10 0QP
114 Worthing Hospital Worthing England United Kingdom BN11 2DH
115 Yeovil District Hospital Yeovil England United Kingdom BA21 4AT
116 Cancer Care Centre at York Hospital York England United Kingdom Y031 8HE
117 Belfast City Hospital Trust Incorporating Belvoir Park Hospital Belfast Northern Ireland United Kingdom BT8 8JR
118 Downe Hospital Downpatrick Northern Ireland United Kingdom BT30 6JA
119 Altnagelvin Area Hospital Londonderry Northern Ireland United Kingdom BT47 1SB
120 Craigavon Area Hospital Portadown, Craigavon Northern Ireland United Kingdom BT63 5QQ
121 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2ZN
122 Ayr Hospital Ayr Scotland United Kingdom KA6 6DX
123 Falkirk and District Royal Infirmary Falkirk Scotland United Kingdom FK1 5QE
124 Western Infirmary Glasgow Scotland United Kingdom G11 6NT
125 Pinderfields General Hospital Wakefield Scotland United Kingdom WF1 4DG
126 Princess of Wales Hospital Bridgend Wales United Kingdom CF31 1JP
127 Velindre Cancer Center at Velindre Hospital Cardiff Wales United Kingdom CF14 2TL
128 University Hospital of Wales Cardiff Wales United Kingdom CF14 4XW
129 Royal Gwent Hospital Newport Gwent Wales United Kingdom NP9 2UB
130 Glan Clwyd Hospital Rhyl, Denbighshire Wales United Kingdom LL 18 5UJ
131 Singleton Hospital Swansea Wales United Kingdom SA2 8QA
132 Queen Victoria Hospital Morecambe United Kingdom LA4 5NN
133 Edith Cavell Hospital Peterborough United Kingdom PE3 9GZ
134 Southlands Hospital Shoreham-by-Sea United Kingdom BN43 6TQ
135 Princess Anne Hospital Southampton United Kingdom SO16 5YA

Sponsors and Collaborators

  • Institute of Cancer Research, United Kingdom

Investigators

  • Principal Investigator: Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00959023
Other Study ID Numbers:
  • CDR0000636371
  • ICR-UKGPCS
  • EU-20909
First Posted:
Aug 14, 2009
Last Update Posted:
Aug 26, 2013
Last Verified:
Aug 1, 2009

Study Results

No Results Posted as of Aug 26, 2013