Study of DNA Mutations in Predicting the Effect of External-Beam Radiation ... | Not Recruiting
Study of DNA Mutations in Predictin... | Not Recruiting
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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Medical Conditions
  • Breast Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Prostate Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00601406

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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.
Research Details
  • 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.
Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Genetic : gene expression analysis, Genetic : gene rearrangement analysis, Genetic : polymorphism analysis, Other : laboratory biomarker analysis, Radiation : radiation therapy

Study Arm Groups : , , , ,

Intervention Type
See Interventions above
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; null
Secondary Outcome Measures
    Comparison of different clinical scoring systems for late normal tissue effects; null; Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera; null; Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS); null; Comparison of detailed 3D dose-volume analysis with late effects and SNP results; null; Correlation of actuarial analysis of late effects changes over time with PRS; null; PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability; null
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
2200
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Cambridge
CB2 2QQ
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich
IP4 5PD
Brighton
BN2 5BE
Southport
PR8 6PN
Cancer Research Centre at Weston Park Hospital
England
S1O 2SJ
Bristol
BS2 8ED
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
St Helens & Knowsley Teaching NHS Trust
Rainhill
Merseyside
L35 5DR
Warrington Hospital NHS Trust
Warrington
England
WA5 1QG
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000581139
Sponsor(s)
The Christie NHS Foundation Trust
Key Dates

Recruitment Start Date

Mar 2006

Recruitment End Date

Feb 2008

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

25 Jan 2008

Date updated in source

23 Aug 2013