Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01322893
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2011-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-20', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment', 'timeFrame': 'Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic breast cancer', 'Circulating tumour cells', 'CTC', 'Prognostic factors', 'Treatment response'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36945037', 'type': 'DERIVED', 'citation': 'Gunnarsdottir FB, Bendahl PO, Johansson A, Benfeitas R, Ryden L, Bergenfelz C, Larsson AM. Serum immuno-oncology markers carry independent prognostic information in patients with newly diagnosed metastatic breast cancer, from a prospective observational study. Breast Cancer Res. 2023 Mar 21;25(1):29. doi: 10.1186/s13058-023-01631-6.'}, {'pmid': '32709042', 'type': 'DERIVED', 'citation': 'Narbe U, Bendahl PO, Aaltonen K, Ferno M, Forsare C, Jorgensen CLT, Larsson AM, Ryden L. The Distribution of Circulating Tumor Cells Is Different in Metastatic Lobular Compared to Ductal Carcinoma of the Breast-Long-Term Prognostic Significance. Cells. 2020 Jul 17;9(7):1718. doi: 10.3390/cells9071718.'}, {'pmid': '29884204', 'type': 'DERIVED', 'citation': 'Larsson AM, Jansson S, Bendahl PO, Levin Tykjaer Jorgensen C, Loman N, Graffman C, Lundgren L, Aaltonen K, Ryden L. Longitudinal enumeration and cluster evaluation of circulating tumor cells improve prognostication for patients with newly diagnosed metastatic breast cancer in a prospective observational trial. Breast Cancer Res. 2018 Jun 8;20(1):48. doi: 10.1186/s13058-018-0976-0.'}, {'pmid': '27390845', 'type': 'DERIVED', 'citation': 'Jansson S, Bendahl PO, Larsson AM, Aaltonen KE, Ryden L. Prognostic impact of circulating tumor cell apoptosis and clusters in serial blood samples from patients with metastatic breast cancer in a prospective observational cohort. BMC Cancer. 2016 Jul 8;16:433. doi: 10.1186/s12885-016-2406-y.'}, {'pmid': '25896421', 'type': 'DERIVED', 'citation': 'Frithiof H, Welinder C, Larsson AM, Ryden L, Aaltonen K. A novel method for downstream characterization of breast cancer circulating tumor cells following CellSearch isolation. J Transl Med. 2015 Apr 21;13:126. doi: 10.1186/s12967-015-0493-1.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/25896421', 'label': 'A novel method for downstream characterization of breast cancer circulating tumor cells following CellSearch isolation. - PubMed - NCBI'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27390845', 'label': 'Prognostic impact of circulating tumor cell apoptosis and clusters in serial blood samples from patients with metastatic breast cancer in a prospec... - PubMed - NCBI'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27895501', 'label': 'A FISH-based method for assessment of HER-2 amplification status in breast cancer circulating tumor cells following CellSearch isolation. - PubMed - NCBI'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/32326116', 'label': 'Evolution of Estrogen Receptor Status from Primary Tumors to Metastasis and Serially Collected Circulating Tumor Cells.'}, {'url': 'https://www.ncbi.nlm.nih.gov//pubmed/32161278', 'label': 'Serial evaluation of serum thymidine kinase activity is prognostic in women with newly diagnosed metastatic breast cancer.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/29884204', 'label': 'Longitudinal CTC and CTC-cluster evaluation improves prognostication and monitoring in metastatic breast cancer patients during 1st line systemic treatment.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed27390845', 'label': 'Prognostic impact of circulating tumor cell apoptosis and clusters in serial blood samples from patients with metastatic breast cancer in a prospective observational cohort.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28489591', 'label': 'Molecular characterization of circulating tumor cells from patients with metastatic breast cancer reflects evolutionary changes in gene expression under the pressure of systemic therapy.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27895501', 'label': 'A FISH-based method for assessment of HER-2 amplification status in breast cancer circulating tumor cells following CellSearch isolation.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/25896421', 'label': 'A novel method for downstream characterization of breast cancer circulating tumor cells following CellSearch isolation.'}]}, 'descriptionModule': {'briefSummary': 'Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with metastatic breast cancer\n* ECOG performance status 0-2\n* Age over18 years\n* Signed informed concent\n* Predicted life expectancy over 2 months\n* Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)\n* Standard imaging evaluation within 4 weeks of inclusion\n* Planned for standard imaging within 16 weeks after start of therapy\n\nExclusion Criteria:\n\n* Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)\n* Inability to understand information about the study\n* Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix'}, 'identificationModule': {'nctId': 'NCT01322893', 'acronym': 'CTC-MBC', 'briefTitle': 'Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'Version2. 2011-03-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood sampling.', 'description': 'Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}