Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00601406
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2008-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D015321', 'term': 'Gene Rearrangement'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2008-01-25', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Comparison of different clinical scoring systems for late normal tissue effects'}, {'measure': 'Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera'}, {'measure': 'Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)'}, {'measure': 'Comparison of detailed 3D dose-volume analysis with late effects and SNP results'}, {'measure': 'Correlation of actuarial analysis of late effects changes over time with PRS'}, {'measure': 'PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability'}]}, 'conditionsModule': {'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', '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'], 'conditions': ['Breast Cancer', 'Cervical Cancer', 'Endometrial Cancer', 'Fallopian Tube Cancer', 'Ovarian Cancer', 'Primary Peritoneal Cavity Cancer', 'Prostate Cancer', 'Sarcoma', 'Vaginal Cancer', 'Vulvar Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* 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.\n* 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.\n* To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history.\n* To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results.\n* To correlate actuarial analysis of late effects changes over time with PRS.\n* 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.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following:\n\n * Early breast cancer after breast-conserving surgery\n * Localized prostate cancer\n * Gynecological cancer (may have also received brachytherapy)\n* Venous blood samples must be available\n* Patients will be identified from the following clinical studies:\n\n * Cambridge intensity-modulated radiotherapy breast randomized trial\n * RT01 prostate radiotherapy randomized trial/other prostate trials\n * Christie hospital breast, prostate, and gynecological cancer radiotherapy patients\n* Must have minimum follow up with late normal tissue effect scoring for two years available\n\nPATIENT CHARACTERISTICS:\n\n* 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\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00601406', 'briefTitle': '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', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)', 'orgStudyIdInfo': {'id': 'CDR0000581139'}, 'secondaryIdInfos': [{'id': 'CHNT-RAPPER'}, {'id': 'EU-20798'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'gene rearrangement analysis', 'type': 'GENETIC'}, {'name': 'polymorphism analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-12-7369-6955'}], 'facility': 'Sussex Cancer Centre at Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-117-928-2415'}], 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1223-336-800'}], 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1473-704-177'}], 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-161-446-8275'}], 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-334-1155'}], 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'L35 5DR', 'city': 'Prescot', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-334-1155'}], 'facility': 'Whiston Hospital', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-114-226-5000'}], 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'PR8 6PN', 'city': 'Southport', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-334-1155'}], 'facility': 'Southport and Formby District General Hospital', 'geoPoint': {'lat': 53.64581, 'lon': -3.01008}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-8661-3271'}], 'facility': 'Royal Marsden - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'WA5 1QG', 'city': 'Warrington', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-334-1155'}], 'facility': 'Warrington Hospital NHS Trust', 'geoPoint': {'lat': 53.39254, 'lon': -2.58024}}], 'overallOfficials': [{'name': 'Catherine West', 'role': 'STUDY_CHAIR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}}}}