|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00601406 |
|
Date of registration:
|
25/01/2008 |
|
Primary sponsor: |
|
|
Public 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
|
|
Scientific title:
|
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER) |
|
Date of first enrolment:
|
March 2006 |
|
Target sample size:
|
2200 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00601406 |
|
Study type:
|
Interventional |
|
Study design:
|
Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Catherine West |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Christie Hospital NHS Foundation Trust |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Cervical Cancer
|
|
Endometrial Cancer
|
|
Fallopian Tube Cancer
|
|
Ovarian Cancer
|
|
Prostate Cancer
|
|
Sarcoma
|
|
Vaginal Cancer
|
|
Vulvar Cancer
|
|
Intervention(s)
|
|
Genetic: gene expression analysis
|
|
Genetic: gene rearrangement analysis
|
|
Genetic: polymorphism analysis
|
|
Other: laboratory biomarker analysis
|
|
Radiation: radiation therapy
|
|
Primary Outcome(s)
|
|
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
[Time Frame: No]
|
|
Secondary Outcome(s)
|
|
Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera
[Time Frame: Yes]
|
|
Comparison of detailed 3D dose-volume analysis with late effects and SNP results
[Time Frame: No]
|
|
Comparison of different clinical scoring systems for late normal tissue effects
[Time Frame: Yes]
|
|
Correlation of actuarial analysis of late effects changes over time with PRS
[Time Frame: No]
|
|
Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)
[Time Frame: 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
[Time Frame: No]
|
|
Secondary ID(s)
|
|
CDR0000581139
|
|
CHNT-RAPPER
|
|
EU-20798
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|