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 - Tabular View

Tracking Information

First Received Date ^ICMJE

January 25, 2008

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00601406 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of different clinical scoring systems for late normal tissue effects [ Designated as safety issue: Yes ]
Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera [ Designated as safety issue: Yes ]
Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS) [ Designated as safety issue: No ]
Comparison of detailed 3D dose-volume analysis with late effects and SNP results [ Designated as safety issue: No ]
Correlation of actuarial analysis of late effects changes over time with PRS [ Designated as safety issue: No ]
PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Breast Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Prostate Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer

Intervention ^ICMJE

Genetic: gene expression analysis
Genetic: gene rearrangement analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2200

Completion Date

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00601406

Responsible Party

Study ID Numbers ^ICMJE

CDR0000581139, CHNT-RAPPER, EU-20798

Study Sponsor ^ICMJE

Christie Hospital NHS Foundation Trust

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Catherine West

Christie Hospital NHS Foundation Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP