Breast CancerNCT00601406
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
A study testing gene expression analysis, gene rearrangement analysis and polymorphism analysis in people with Breast Cancer and Cervical Cancer, run by The Christie NHS Foundation Trust at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Endometrial Cancer
- What is being tested?
- gene expression analysis, gene rearrangement analysis and polymorphism analysis
- Type of treatment
- Surgery or procedure
- How many people
- 2,200 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Mar 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites, 11 recruiting
- Recruiting
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Contact Person, 44-12-7369-6955
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Contact Person, 44-117-928-2415
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Contact Person, 44-1223-336-800
- Recruiting
Ipswich Hospital
Ipswich, England, IP4 5PD
Contact Person, 44-1473-704-177
- Recruiting
Christie Hospital
Manchester, England, M20 4BX
Contact Person, 44-161-446-8275
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Contact Person, 44-151-334-1155
- Recruiting
Whiston Hospital
Prescot, England, L35 5DR
Contact Person, 44-151-334-1155
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Contact Person, 44-114-226-5000
- Recruiting
Southport and Formby District General Hospital
Southport, England, PR8 6PN
Contact Person, 44-151-334-1155
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8661-3271
- Recruiting
Warrington Hospital NHS Trust
Warrington, England, WA5 1QG
Contact Person, 44-151-334-1155
About this study
Official title: Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
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.
Read the 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
- Breast Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- gene expression analysis, gene rearrangement analysis, polymorphism analysis, laboratory biomarker analysis, radiation therapy
- 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
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Sarcoma, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
gene rearrangement analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Catherine West, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601406
- Sponsor's protocol ID
- CDR0000581139
- Other IDs
- CHNT-RAPPER, EU-20798
- Status last verified
- Apr 2008
- First submitted
- 25 Jan 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
- ClinicalTrials.gov ID
- NCT00601406
- Acronym / sponsor ID
- CDR0000581139
- Conditions
- Breast Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2008 (estimated)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| gene rearrangement analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| radiation therapy | Radiation | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine West study chair
The Christie NHS Foundation Trust
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gene expression analysis, gene rearrangement analysis and polymorphism analysis in people with Breast Cancer and Cervical Cancer, run by The Christie NHS Foundation Trust at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.