Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-06 @ 9:48 AM
Study NCT ID:
NCT04145960
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for 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': '1 mL of blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immune inflammation-related protein complexes', 'timeFrame': '2 years', 'description': 'The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography.'}, {'measure': 'blood markers', 'timeFrame': '2 years', 'description': 'The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.', 'detailedDescription': '200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with high risk of recurrence and metastasis of breast cancer', 'genderDescription': 'The participant eligibility is based on the physiological sex.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors\n* Breast cancer-related chemotherapy and radiotherapy completed\n* axillary lymph node metastasis ≥ 4\n* age ≤ 60 years old\n\nExclusion Criteria:\n\n* Male\n* Aged above 60\n* Breast Carcinoma in situ\n* Women in pregnancy or breastfeeding\n* Suffering from other malignant tumors\n* Non-compliant patient'}, 'identificationModule': {'nctId': 'NCT04145960', 'briefTitle': 'Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood', 'orgStudyIdInfo': {'id': 'PUMCH-BC500'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lymph node metastasis', 'description': 'Axillary lymph node metastasis ≥ 4 Lymph nodes'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yali Xu', 'role': 'CONTACT', 'email': '49950757@qq.com', 'phone': '+86-13717761030'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yali Xu', 'role': 'CONTACT', 'email': '49950757@qq.com', 'phone': '+86-13717761030'}], 'overallOfficials': [{'name': 'Yali Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yali XU', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}