Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT07167433
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of socio-demographic characteristics', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are begin performed for the primary outcomes of this study."}, {'measure': 'Description of pathological characteristics', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are being performed for the primary outcomes of this study."}, {'measure': 'Description of treatment', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are being performed for the primary outcomes of this study."}], 'secondaryOutcomes': [{'measure': 'Treatment interval of systemic therapy in metastatic disease', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are beign performed for the outcomes of this study."}, {'measure': 'Disease free-survival', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are beign performed for the outcomes of this study."}, {'measure': 'Time to next chemotherapy', 'timeFrame': 'Throught study a completation, an average of 3 years', 'description': "The study's findings could provide a basis for evaluating current practices in ovarian treatment and other characteristics about this disease.\n\nBy identifying strengths and weaknesses in existing care, the project aims to offer insights that may lead to the implementation of quality parameters for ovarian cancer treatment in the country.\n\nNo formal statistical comparisons are beign performed for the outcomes of this study."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The findings from this study have the potential to serve as a foundation for evaluating the current practices related to surgical procedures, systemic therapies, hyperthermic intraperitoneal chemotherapy, and referrals to geneticists for OC patients. By identifying the strengths and weaknesses of the existing care, this project intends to generate valuable insights that can lead to the implementation of quality parameters for the treatment of ovarian cancer in the country.', 'detailedDescription': 'This study is an observational, bi-directional (prospective and retrospective) analytical study designed to assess the sociodemographic, clinical, and pathological characteristics of patients with ovarian cancer, stages IA to IVB, as well as those with persistent or recurrent disease. The study will include 250 patients who meet the eligibility criteria of being 18 years or older, with a diagnosis of ovarian cancer from January 2021, irrespective of histology, over a 1-year enrollment period across 20 participating sites.\n\nUpon enrollment, baseline data will be collected, which includes sociodemographic details, clinical information, pathological findings, and genetic testing and counseling data. Follow-up data will be gathered at 12, 24, and 36 months to monitor treatment patterns and outcomes. These data collection points will allow for the evaluation of both short-term and long-term outcomes, providing valuable insights into the progression and management of ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study base consists of patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards.', 'genderDescription': 'The study base consists of patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards. The study will span 20 research sites across diverse geographical locations, ensuring a broad representation of different healthcare settings and patient demographics. The study population will include patients aged 18 years and older, irrespective of histological subtype. Over a 12-month enrollment period, a total of 250 patients are expected to be included in the study. The follow-up period will extend for 3 years, with data collection occurring at 12, 24, and 36 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years old;\n* Newly diagnosed ovarian cancer stages IA to IVB, or persistent or recurrent disease from January 2021;\n* Irrespective of histology\n\nExclusion Criteria:\n\n* Borderline tumors;\n* Pregnancy;\n* Synchronous tumor or second primary in the last 5 years (except thyroid cancer and non-melanoma skin cancer);'}, 'identificationModule': {'nctId': 'NCT07167433', 'acronym': 'OLIVIA', 'briefTitle': 'Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Ovarian Cancer Epidemiology and Care in Brazil: A Multicenter Perspective (OLIVIA Study) Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology', 'orgStudyIdInfo': {'id': 'D133HR00051'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'patients newly diagnosed with ovarian cancer across stages IA to IVB, and those with persistent or recurrent disease, diagnosed from January 2021 onwards'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}