Study of DNA Mutations in Predicting the Effect of Extern... | NCT00601406 | Trialant
NCT00601406
Sponsor
The Christie NHS Foundation Trust
Status
Unknown status
Last Update Posted
Aug 26, 2013Estimated
Enrollment
2,200Estimated
Phase
Not Applicable
Conditions
Breast Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Prostate Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Interventions
gene expression analysis
gene rearrangement analysis
polymorphism analysis
laboratory biomarker analysis
radiation therapy
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00601406
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000581139
Secondary IDs
ID
Type
Description
Link
CHNT-RAPPER
EU-20798
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)
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Apr 2008
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2006
Primary Completion Date
Feb 2008Estimated
Completion Date
Not provided
First Submitted Date
Jan 25, 2008
First Submission Date that Met QC Criteria
Jan 25, 2008
First Posted Date
Jan 28, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 23, 2013
Last Update Posted Date
Aug 26, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
The Christie NHS Foundation TrustOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
2,200Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
gene expression analysis
Genetic
gene rearrangement analysis
Genetic
polymorphism analysis
Genetic
laboratory biomarker analysis
Other
radiation therapy
Radiation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
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
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Catherine West
The Christie NHS Foundation Trust
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sussex Cancer Centre at Royal Sussex County Hospital
Recruiting
Brighton
England
BN2 5BE
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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
Contact PersonContact44-12-7369-6955
Bristol Haematology and Oncology Centre
Recruiting
Bristol
England
BS2 8ED
United Kingdom
Contact PersonContact44-117-928-2415
Addenbrooke's Hospital
Recruiting
Cambridge
England
CB2 2QQ
United Kingdom
Contact PersonContact44-1223-336-800
Ipswich Hospital
Recruiting
Ipswich
England
IP4 5PD
United Kingdom
Contact PersonContact44-1473-704-177
Christie Hospital
Recruiting
Manchester
England
M20 4BX
United Kingdom
Contact PersonContact44-161-446-8275
Clatterbridge Centre for Oncology
Recruiting
Merseyside
England
CH63 4JY
United Kingdom
Contact PersonContact44-151-334-1155
Whiston Hospital
Recruiting
Prescot
England
L35 5DR
United Kingdom
Contact PersonContact44-151-334-1155
Cancer Research Centre at Weston Park Hospital
Recruiting
Sheffield
England
S1O 2SJ
United Kingdom
Contact PersonContact44-114-226-5000
Southport and Formby District General Hospital
Recruiting
Southport
England
PR8 6PN
United Kingdom
Contact PersonContact44-151-334-1155
Royal Marsden - Surrey
Recruiting
Sutton
England
SM2 5PT
United Kingdom
Contact PersonContact44-20-8661-3271
Warrington Hospital NHS Trust
Recruiting
Warrington
England
WA5 1QG
United Kingdom
Contact PersonContact44-151-334-1155
ID
Term
D001943
Breast Neoplasms
D002583
Uterine Cervical Neoplasms
D016889
Endometrial Neoplasms
D005185
Fallopian Tube Neoplasms
D010051
Ovarian Neoplasms
D011471
Prostatic Neoplasms
D012509
Sarcoma
D014625
Vaginal Neoplasms
D014846
Vulvar Neoplasms
D018567
Breast Neoplasms, Male
D000077216
Carcinoma, Ovarian Epithelial
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications