Last updated: 03/05/2025 08:50:14
Epidemiology, real-world treatment patterns and survival in newly diagnosed ovarian cancer in German participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Description of epidemiology, real-world treatment patterns and survival in newly diagnosed ovarian cancer patients in Germany: a study based on the AGO QS database, a German cohort of ovarian cancer patients
Trial description: This observational retrospective study aims to analyze a German real-world dataset of individuals with ovarian cancer (OC) to describe and better understand the participant’s characteristics, disease characteristics, treatments patterns and survival outcomes of ovarian cancer participants in Germany.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Demographic characteristics, clinical characteristics, treatment pathways for subgroup population
Timeframe: Up to 4 years
Demographic characteristics, clinical characteristics, treatment pathways for overall study population
Timeframe: Up to 4 years
Secondary outcomes:
Number of participants newly diagnosed with OC
Timeframe: Up to 4 years
Number of participants with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer in response (complete or partial) following completion of first-line (1L) platinum-based chemotherapy
Timeframe: Up to 4 years
Overall survival (OS) after receiving 1L platinum-based chemotherapy
Timeframe: Up to 4 years
Progression-free survival (PFS) after receiving 1L platinum-based chemotherapy
Timeframe: Up to 4 years
Second PFS (PFS2) after receiving 1L platinum-based chemotherapy
Timeframe: Up to 4 years
Time to first subsequent treatment (TFST) after receiving 1L platinum-based chemotherapy
Timeframe: Up to 4 years
Time to second subsequent treatment (TSST) after receiving 1L platinum-based chemotherapy
Timeframe: Up to 4 years
Time to next treatment after 1L chemotherapy (TTNT1)
Timeframe: Up to 4 years
Number of participants with recurrent OC
Timeframe: Up to 4 years
Number of participants with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (2L)
Timeframe: Up to 4 years
OS since second line treatment (OS 2L)
Timeframe: Up to 4 years
PFS since second line treatment (PFS 2L)
Timeframe: Up to 4 years
TTNT after second line treatment (TTNT2)
Timeframe: Up to 4 years
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-07-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2021 to April 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Adult females (18 plus [+]) at the date of primary ovarian cancer diagnosis
- With primary diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 01-Jun-2012 and 30-Sep-2012 (cohort 2012) as well as between 01-Jun-2016 and 30-Sep-2016.
- Patient with borderline-tumor (low malignant potential)
- Patient with germ-cell tumors.
Inclusion and exclusion criteria
Inclusion criteria:
- Adult females (18 plus [+]) at the date of primary ovarian cancer diagnosis
- With primary diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 01-Jun-2012 and 30-Sep-2012 (cohort 2012) as well as between 01-Jun-2016 and 30-Sep-2016.
Exclusion criteria:
- Patient with borderline-tumor (low malignant potential)
- Patient with germ-cell tumors.
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
2022-07-04
Actual study completion date
2022-07-04
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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