NCT00601406

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for not_applicable breast-cancer

Geographic Reach
1 country

11 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

August 26, 2013

Status Verified

April 1, 2008

Enrollment Period

1.9 years

First QC Date

January 25, 2008

Last Update Submit

August 23, 2013

Conditions

Breast CancerCervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity CancerProstate CancerSarcomaVaginal CancerVulvar Cancer

Keywords

male breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IA cervical cancerstage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancerstage I vaginal cancerstage II vaginal cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerstage IA vulvar cancerstage IB vulvar cancerstage II vulvar cancerstage IIIC vulvar cancerstage IIIA vulvar cancerstage IIIB vulvar cancerstage IVB vulvar cancerstage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IA ovarian germ cell tumorstage IB ovarian germ cell tumorstage IC ovarian germ cell tumorstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIA ovarian germ cell tumorstage IIB ovarian germ cell tumorstage IIC ovarian germ cell tumorstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IIIA ovarian germ cell tumorstage IIIB ovarian germ cell tumorstage IIIC ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorstage II endometrial carcinomaovarian stromal cancerovarian sarcomastage IA fallopian tube cancerstage IB fallopian tube cancerstage IC fallopian tube cancerstage IIA fallopian tube cancerstage IIB fallopian tube cancerstage IIC fallopian tube cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancerstage IV fallopian tube cancerrecurrent primary peritoneal cavity cancerstage IA primary peritoneal cavity cancerstage IB primary peritoneal cavity cancerstage IC primary peritoneal cavity cancerstage IIA primary peritoneal cavity cancerstage IIB primary peritoneal cavity cancerstage IIC primary peritoneal cavity cancerstage IIIA primary peritoneal cavity cancerstage IIIB primary peritoneal cavity cancerstage IIIC primary peritoneal cavity cancerstage IV primary peritoneal cavity cancerstage IA endometrial carcinomastage IB endometrial carcinomastage IIIA endometrial carcinomastage IIIB endometrial carcinomastage IIIC endometrial carcinomastage IVA endometrial carcinomastage IVB endometrial carcinomastage IA uterine sarcomastage IB uterine sarcomastage IC uterine sarcomastage IIA uterine sarcomastage IIB uterine sarcomastage IIIA uterine sarcomastage IIIB uterine sarcomastage IIIC uterine sarcomastage IVA uterine sarcomastage IVB uterine sarcoma

Outcome Measures

Primary Outcomes (1)

  • Correlation of association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, with individual patient variability in normal tissue radiation response and toxicity

Secondary Outcomes (6)

  • Comparison of different clinical scoring systems for late normal tissue effects

  • Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera

  • Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)

  • Comparison of detailed 3D dose-volume analysis with late effects and SNP results

  • Correlation of actuarial analysis of late effects changes over time with PRS

  • +1 more secondary outcomes

Interventions

gene expression analysisGENETIC
gene rearrangement analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following: * Early breast cancer after breast-conserving surgery * Localized prostate cancer * Gynecological cancer (may have also received brachytherapy) * Venous blood samples must be available * Patients will be identified from the following clinical studies: * Cambridge intensity-modulated radiotherapy breast randomized trial * RT01 prostate radiotherapy randomized trial/other prostate trials * Christie hospital breast, prostate, and gynecological cancer radiotherapy patients * Must have minimum follow up with late normal tissue effect scoring for two years available PATIENT CHARACTERISTICS: * No other malignancy prior to treatment for the specified tumor types except basal cell or squamous cell carcinoma of the skin or in situ carcinoma PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (11)

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

RECRUITING

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

RECRUITING

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

RECRUITING

Whiston Hospital

Prescot, England, L35 5DR, United Kingdom

RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

Southport and Formby District General Hospital

Southport, England, PR8 6PN, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsProstatic NeoplasmsSarcomaVaginal NeoplasmsVulvar NeoplasmsBreast Neoplasms, MaleCarcinoma, Ovarian Epithelial

Interventions

Gene Expression ProfilingGene RearrangementAmplified Fragment Length Polymorphism AnalysisRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeVaginal DiseasesVulvar DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesGenetic PhenomenaDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification TechniquesTherapeutics

Study Officials

  • Catherine West

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2008

First Posted

January 28, 2008

Study Start

March 1, 2006

Primary Completion

February 1, 2008

Last Updated

August 26, 2013

Record last verified: 2008-04

Locations

GB(11)