Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 3:34 PM
Study NCT ID:
NCT04683757
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The target of this study is to detect the gene mutation of tumor tissue or peripheral blood circulation tumor DNA of tumor patients. 10ml of tissue or fresh peripheral blood should be collected as the test sample and stored at room temperature. On the same day, it was sent to the "cell and molecular diagnosis center" of our hospital for DNA isolation and extraction, secondary sequencing, and detection of related biomarkers, such as erbB2 / TP53 / PIK3CA / ErbB4 / CCND1.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-19', 'studyFirstSubmitDate': '2020-12-19', 'studyFirstSubmitQcDate': '2020-12-19', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival，OS', 'timeFrame': '5 years', 'description': 'The time from the beginning of treatment to the death of the patient'}, {'measure': 'Tumor specific survival time, CSS', 'timeFrame': '5 years', 'description': 'The follow-up started from the first day of confirmed recurrence and metastasis. The end point of follow-up was the death caused by tumor related causes.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival，PFS', 'timeFrame': '2 years', 'description': 'The time from the beginning of treatment to the progression or death of the patient.'}, {'measure': '5-year survival rate', 'timeFrame': '5 years', 'description': 'the survival rate in 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'a Survival Prediction Model'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At the time of signing the informed consent form, 18 years old ≤ 70 years old, female\n2. ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry\n3. Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit\n4. Patients who are willing to receive follow-up treatment in the research center.\n\nExclusion Criteria:\n\n1. ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.\n2. Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions\n3. Combined with other malignant tumors or had other malignant tumors in recent 5 years\n4. Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state\n5. Patients with life expectancy less than 3 months"}, 'identificationModule': {'nctId': 'NCT04683757', 'briefTitle': 'The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer', 'orgStudyIdInfo': {'id': '2017-KY-19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Establishment of a Survival Prediction Model', 'type': 'OTHER', 'description': 'a nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Sun Yat Sen Memorial Hospital，Sun Yat sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Wang', 'role': 'CONTACT', 'email': 'wangy556@mail.sysu.edu.cn', 'phone': '86-020-34070870'}, {'name': 'Jianli Zhao', 'role': 'CONTACT', 'email': 'zhaojli5@mail.sysu.edu.cn', 'phone': '86-020-34070499'}], 'facility': 'Sun Yat-sen Memorial Hospital， Sun Yat-sen University', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}], 'centralContacts': [{'name': 'Ying Dr. Wang, doctor', 'role': 'CONTACT', 'email': 'wangy556@mail.sysu.edu.cn', 'phone': '86-20-34070499'}, {'name': 'Jianli Zhao', 'role': 'CONTACT', 'email': 'zhaojli5@mail.sysu.edu.cn', 'phone': '86-20-34070870'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ying Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ying Wang', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}