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
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.
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
England
-
Brighton、England、英国、BN2 5BE
- 招聘中
- Sussex Cancer Centre at Royal Sussex County Hospital
-
接触:
- Contact Person
- 电话号码:44-12-7369-6955
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Bristol、England、英国、BS2 8ED
- 招聘中
- Bristol Haematology and Oncology centre
-
接触:
- Contact Person
- 电话号码:44-117-928-2415
-
Cambridge、England、英国、CB2 2QQ
- 招聘中
- Addenbrooke's Hospital
-
接触:
- Contact Person
- 电话号码:44-1223-336-800
-
Ipswich、England、英国、IP4 5PD
- 招聘中
- Ipswich Hospital
-
接触:
- Contact Person
- 电话号码:44-1473-704-177
-
Manchester、England、英国、M20 4BX
- 招聘中
- Christie Hospital
-
接触:
- Contact Person
- 电话号码:44-161-446-8275
-
Merseyside、England、英国、CH63 4JY
- 招聘中
- Clatterbridge Centre for Oncology
-
接触:
- Contact Person
- 电话号码:44-151-334-1155
-
Prescot、England、英国、L35 5DR
- 招聘中
- Whiston Hospital
-
接触:
- Contact Person
- 电话号码:44-151-334-1155
-
Sheffield、England、英国、S1O 2SJ
- 招聘中
- Cancer Research Centre at Weston Park Hospital
-
接触:
- Contact Person
- 电话号码:44-114-226-5000
-
Southport、England、英国、PR8 6PN
- 招聘中
- Southport and Formby District General Hospital
-
接触:
- Contact Person
- 电话号码:44-151-334-1155
-
Sutton、England、英国、SM2 5PT
- 招聘中
- Royal Marsden - Surrey
-
接触:
- Contact Person
- 电话号码:44-20-8661-3271
-
Warrington、England、英国、WA5 1QG
- 招聘中
- Warrington Hospital NHS Trust
-
接触:
- Contact Person
- 电话号码:44-151-334-1155
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
---|
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
|
次要结果测量
结果测量 |
---|
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
|
合作者和调查者
调查人员
- 学习椅:Catherine West、The Christie NHS Foundation Trust
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- III期前列腺癌
- IV期卵巢上皮癌
- 男性乳腺癌
- II期乳腺癌
- IA期乳腺癌
- IB期乳腺癌
- 复发性原发性腹膜腔癌
- I期前列腺癌
- IIB期前列腺癌
- IIA期前列腺癌
- IIB期宫颈癌
- III期宫颈癌
- IVA期宫颈癌
- IB期宫颈癌
- IIA期宫颈癌
- IA期卵巢上皮癌
- IB期卵巢上皮癌
- IC期卵巢上皮癌
- IIA期卵巢上皮癌
- IIB期卵巢上皮癌
- IIC期卵巢上皮癌
- IIIA期卵巢上皮癌
- IIIB期卵巢上皮癌
- IIIC期卵巢上皮癌
- IA期原发性腹膜腔癌
- IB期原发性腹膜腔癌
- IC期原发性腹膜腔癌
- IIA期原发性腹膜腔癌
- IIB期原发性腹膜腔癌
- IIC期原发性腹膜腔癌
- IIIA期原发性腹膜腔癌
- IIIB期原发性腹膜腔癌
- IIIC期原发性腹膜腔癌
- IA期输卵管癌
- IB期输卵管癌
- IC期输卵管癌
- IIA期输卵管癌
- IIB期输卵管癌
- IIC期输卵管癌
- IIIA期输卵管癌
- IIIB期输卵管癌
- IIIC期输卵管癌
- 卵巢肉瘤
- IA期宫颈癌
- IVB期宫颈癌
- 卵巢间质癌
- IV期卵巢生殖细胞瘤
- III期阴道癌
- IVA期阴道癌
- IVB期阴道癌
- IIA期卵巢生殖细胞肿瘤
- IIB期卵巢生殖细胞肿瘤
- IIC期卵巢生殖细胞肿瘤
- IIIA期卵巢生殖细胞瘤
- IIIB期卵巢生殖细胞肿瘤
- IIIC期卵巢生殖细胞肿瘤
- I期阴道癌
- II期阴道癌
- stage IA vulvar cancer
- stage IB vulvar cancer
- II期外阴癌
- stage IIIC vulvar cancer
- stage IIIA vulvar cancer
- stage IIIB vulvar cancer
- IVB期外阴癌
- IA期卵巢生殖细胞肿瘤
- IB期卵巢生殖细胞肿瘤
- IC期卵巢生殖细胞肿瘤
- II期子宫内膜癌
- IV期输卵管癌
- IV期原发性腹膜腔癌
- IA期子宫内膜癌
- IB期子宫内膜癌
- IIIA期子宫内膜癌
- IIIB期子宫内膜癌
- IIIC期子宫内膜癌
- 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
- IIIA期子宫肉瘤
- IIIB期子宫肉瘤
- IIIC期子宫肉瘤
- IVA期子宫肉瘤
- IVB期子宫肉瘤
其他相关的 MeSH 术语
其他研究编号
- CDR0000581139
- CHNT-RAPPER
- EU-20798
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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