Last updated: 08/07/2025 05:30:09
Understanding the sequencing and treatment patterns of maintenance therapy using Integra Connect
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Treatment Journey of Patients Diagnosed with Advanced-Stage Ovarian Cancer
Trial description: This study aims to understand the treatment patterns and selection of maintenance treatment among advanced stage ovarian cancer patients treated in the real-world study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of participants with and without bevacizumab
Timeframe: Up to 3 months
Time between initiation of maintenance and completion of induction therapy
Timeframe: Up to 3 months
Proportion of participants with and without maintenance treatment
Timeframe: Up to 3 months
Number of participants using Maintenance therapy and type of Maintenance therapy based on biomarker status
Timeframe: Up to 3 months
Proportion of participants with and without LOT 1 maintenance therapy based on the biomarker status
Timeframe: Up to 3 months
Proportion of patients with change in dose of PARP inhibitors
Timeframe: Up to 3 months
Proportion of Participants who switched maintenance drugs following LOT 1
Timeframe: Up to 3 months
Secondary outcomes:
Proportion of participants with demographic and clinical characteristics
Timeframe: Up to 3 months
Proportion of participants with germline testing for BRCA
Timeframe: Up to 3 months
Proportion of participants with somatic testing for BRCA and HRD
Timeframe: Up to 3 months
Effective testing rate in relation to the maintenance treatment
Timeframe: Up to 3 months
Proportions of participants with test results post initiation of maintenance treatment
Timeframe: Up to 3 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-24-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2022 to October 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Female adults 18 years of age or older at diagnosis
- Participants Diagnosed with the following International Classification of Diseases (ICD) 10 codes
- Participants without a visit within the Service Provider Network within 90 days of Ovarian cancer (OC) diagnosis
- Participants who received treatment for another primary cancer following index date and before the end of the study observation period
Inclusion and exclusion criteria
Inclusion criteria:
- Female adults 18 years of age or older at diagnosis
- Participants Diagnosed with the following International Classification of Diseases (ICD) 10 codes o C56.x Malignant neoplasm of ovary o C57.0 Malignant neoplasm of unspecified fallopian tube o C57.01 Malignant neoplasm of right fallopian tube o C57.02 Malignant neoplasm of left fallopian tube o C48.1 Malignant neoplasm of specified parts of peritoneum o C48.2 Malignant neoplasm of peritoneum, unspecified o C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
- Participants is diagnosed with stage III or IV
- Participants who started 1st line of therapy during study identification period
- Participants with 2 or more evaluation and management visits
- Participants belong to large-multi-site community oncology practice or single-site community oncology practice
Exclusion criteria:
- Participants without a visit within the Service Provider Network within 90 days of Ovarian cancer (OC) diagnosis
- Participants who received treatment for another primary cancer following index date and before the end of the study observation period
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-24-10
Actual study completion date
2022-24-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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