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Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer

Primary Purpose

Breast Cancer, Cervical Cancer, Endometrial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
gene expression analysis
gene rearrangement analysis
polymorphism analysis
laboratory biomarker analysis
radiation therapy
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, stage I vaginal cancer, stage II vaginal cancer, stage III vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, stage IA vulvar cancer, stage IB vulvar cancer, stage II vulvar cancer, stage IIIC vulvar cancer, stage IIIA vulvar cancer, stage IIIB vulvar cancer, stage IVB vulvar cancer, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IA ovarian germ cell tumor, stage IB ovarian germ cell tumor, stage IC ovarian germ cell tumor, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIA ovarian germ cell tumor, stage IIB ovarian germ cell tumor, stage IIC ovarian germ cell tumor, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, stage II endometrial carcinoma, ovarian stromal cancer, ovarian sarcoma, stage IA fallopian tube cancer, stage IB fallopian tube cancer, stage IC fallopian tube cancer, stage IIA fallopian tube cancer, stage IIB fallopian tube cancer, stage IIC fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer, stage IIB primary peritoneal cavity cancer, stage IIC primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, stage IVA endometrial carcinoma, stage IVB endometrial carcinoma, stage IA uterine sarcoma, stage IB uterine sarcoma, stage IC uterine sarcoma, stage IIA uterine sarcoma, stage IIB uterine sarcoma, stage IIIA uterine sarcoma, stage IIIB uterine sarcoma, stage IIIC uterine sarcoma, stage IVA uterine sarcoma, stage IVB uterine sarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sussex Cancer Centre at Royal Sussex County HospitalRecruiting
  • Bristol Haematology and Oncology CentreRecruiting
  • Addenbrooke's HospitalRecruiting
  • Ipswich HospitalRecruiting
  • Christie HospitalRecruiting
  • Clatterbridge Centre for OncologyRecruiting
  • Whiston HospitalRecruiting
  • Cancer Research Centre at Weston Park HospitalRecruiting
  • Southport and Formby District General HospitalRecruiting
  • Royal Marsden - SurreyRecruiting
  • Warrington Hospital NHS TrustRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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
PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability

Full Information

First Posted
January 25, 2008
Last Updated
August 23, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00601406
Brief Title
Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer
Official Title
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary To test the hypothesis that an association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, is associated with individual patient variability in normal tissue radiation response and toxicity. Secondary To compare different clinical scoring systems for late normal tissue effects, specifically Late Effect of Normal Tissue Subjective Objective Management Analysis (LENT SOMA), Radiation Therapy Oncology Group (RTOG), quality of life, and in a subset common terminology criteria (CTC) version 3. To compare clinical scoring systems with analytical measures of normal tissue outcome in a minority of patients, using volume change in the breast measured by laser camera. To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history. To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results. To correlate actuarial analysis of late effects changes over time with PRS. To conduct PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability. OUTLINE: This is a multicenter study. Patients are recruited from clinical trials in which their late normal tissue effects have been measured. Blood samples are collected from these patients for analysis of genetic variation by DNA extraction and single nucleotide polymorphism analysis. Sixty different genes, including those involved in cell cycle checkpoint control, DNA damage recognition and repair, induction of apoptosis, and cytokine production (including TGFβ pathways) are assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer, Prostate Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer
Keywords
male breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, stage I vaginal cancer, stage II vaginal cancer, stage III vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, stage IA vulvar cancer, stage IB vulvar cancer, stage II vulvar cancer, stage IIIC vulvar cancer, stage IIIA vulvar cancer, stage IIIB vulvar cancer, stage IVB vulvar cancer, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IA ovarian germ cell tumor, stage IB ovarian germ cell tumor, stage IC ovarian germ cell tumor, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIA ovarian germ cell tumor, stage IIB ovarian germ cell tumor, stage IIC ovarian germ cell tumor, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, stage II endometrial carcinoma, ovarian stromal cancer, ovarian sarcoma, stage IA fallopian tube cancer, stage IB fallopian tube cancer, stage IC fallopian tube cancer, stage IIA fallopian tube cancer, stage IIB fallopian tube cancer, stage IIC fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer, stage IIB primary peritoneal cavity cancer, stage IIC primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, stage IVA endometrial carcinoma, stage IVB endometrial carcinoma, stage IA uterine sarcoma, stage IB uterine sarcoma, stage IC uterine sarcoma, stage IIA uterine sarcoma, stage IIB uterine sarcoma, stage IIIA uterine sarcoma, stage IIIB uterine sarcoma, stage IIIC uterine sarcoma, stage IVA uterine sarcoma, stage IVB uterine sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
gene rearrangement analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Comparison of different clinical scoring systems for late normal tissue effects
Title
Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera
Title
Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)
Title
Comparison of detailed 3D dose-volume analysis with late effects and SNP results
Title
Correlation of actuarial analysis of late effects changes over time with PRS
Title
PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine West
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-12-7369-6955
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-117-928-2415
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1223-336-800
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1473-704-177
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-161-446-8275
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-334-1155
Facility Name
Whiston Hospital
City
Prescot
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-334-1155
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-114-226-5000
Facility Name
Southport and Formby District General Hospital
City
Southport
State/Province
England
ZIP/Postal Code
PR8 6PN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-334-1155
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8661-3271
Facility Name
Warrington Hospital NHS Trust
City
Warrington
State/Province
England
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-334-1155

12. IPD Sharing Statement

Learn more about this trial

Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer

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