Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer

Browse trials for

• Ovarian Neoplasms 2,695

Keywords

• Patient reported outcome (PRO),
• advanced Ovarian Cancer

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 752 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study population

Groups and cohorts

• PARPi maintenance cohort (PMC)

  patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX

• Bevacizumab maintenance cohort (BMC)

  patients who continue to receive at least one dose of bevacizumab after 1L platinum-based CTX and who have not received PARPi MTX treatment

• No maintenance cohort (NMC)

  patients who never received any 1L MTX treatment (PARPi or bevacizumab)

Primary outcomes

1. progression-free survival (PFS)

   The primary outcome is progression-free survival (PFS) defined as time from 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals for tumor assessments are at the discretion of the treating physician. Details on progression incl. the procedure used to confirm progression (e.g. symptoms, ultrasound, x-ray, CT, MRI) will be captured in the eCRF.

   Time frame: date of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months

Secondary outcomes

1. Recurrence-free survival (RFS)

   Recurrence-free survival (RFS) is time from 1st dose of 1L platinum-based CTX to disease recurrence (investigator-assessed according to clinical routine) or death of any cause defined as in patients with no evidence of disease (NED) following platinum-based CTX

   Time frame: time of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months

2. Progression-/recurrence-free survival rate

   Progression-/recurrence-free survival rate is defined as the percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years derived by Kaplan-Meier methods in the full analysis set/subset of patients with NED; Patients within NED subset will be considered as long-term disease-free survivors (potentially cured) if they are disease free for the whole period of 7 years

   Time frame: percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years

3. Time to first subsequent therapy (TFST)

   Time to first subsequent therapy (TFST) is defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of subsequent therapy or death of any cause;

   Time frame: time from 1st dose of 1L platinum-based CTX to the 1st dose of subsequent therapy or death of any cause, whichever came first, assessed up to 84 months

4. Second progression-free survival (PFS2)

   Second progression-free survival (PFS2) is defined as time from 1st dose of 1L platinum-based CTX to second disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals of tumor assessments are at the discretion of the treating physician and will be recorded in the eCRF

   Time frame: time from 1st dose of 1L platinum-based CTX to second disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months

5. Time to second subsequent therapy (TSST)

   Time to second subsequent therapy (TSST) as time from 1st dose of 1L platinum-based CTX to the 1st dose of second subsequent therapy or death of any cause

   Time frame: time from 1st dose of 1L platinum-based CTX to the 1st dose of second subsequent therapy or death of any cause, whichever came first, assessed up to 84 months

6. 3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.)

   3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.) is defined as time from 1st dose of 1L platinum-based CTX to 3rd, 4th, 5th and later disease progression \[investigator-assessed according to clinical routine\] or death of any cause). Methods and intervals of tumor assessments are at the discretion of the treating physician and will be recorded in the eCRF

   Time frame: time from 1st dose of 1L platinum-based CTX to 3rd, 4th, 5th and later disease progression [investigator-assessed according to clinical routine] or death of any cause, whichever came first, assessed up to 84 months

7. Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.)

   Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.) is defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of 3rd, 4th, 5th and later subsequent therapy or death of any cause

   Time frame: defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of 3rd, 4th, 5th and later subsequent therapy or death of any cause, whichever came first, assessed up to 84 months

8. Overall survival (OS)

   Overall survival (OS) is defined as time from 1st dose of 1L platinum-based CTX to death of any cause

   Time frame: time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months

9. Patient-reported health-related quality of life (HRQoL) - EQ-5D questionnaire

   The EQ-5D is a standardized measure of health status applicable to a wide range of health conditions and treatments designed by the EuroQoL Group (EQ). It consists of the EQ-5D descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each dimension having 5 levels (5L), and the EQ visual analogue scale (EQ VAS).

   Time frame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months

10. Patient-reported health-related quality of life (HRQoL) - FACT-O questionnaire

    Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Quality of life of women with OC is assessed by means of the FACT-O questionnaire. It contains questions addressing the most frequent problems of cancer patients: physical well-being, social/family well-being, emotional well-being, functional well-being, as well as additional concerns specific to OC (such as female-specific concerns and abdominal problems)

    Time frame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months

11. Patient-reported health-related quality of life (HRQoL) - MOSTv2 questionnaire

    Measure of Ovarian Symptoms and Treatment concerns Version 2 (MOSTv2) The MOST quantifies patient-reported symptom burden, adverse effects, and symptom benefit in OC patients. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being

    Time frame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months

12. Patient-reported health-related quality of life (HRQoL) - PGI-S questionnaire

    Patient global impression of severity of cancer symptoms (PGI-S) is a one-item scale to assess a patient's impression of disease severity on a four-point scale from normal to severe.

    Time frame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months

Other outcomes

1. Patient's expectations/needs

   Patient's expectations/needs for support/information/education regarding the disease itself and the current therapy (systemic therapies during surgery, CTX, MTX, FU, long-term survivor) as determined by unstandardized questionnaire partially based on EXPRESSION IV questionnaire and open questioning

   Time frame: at baseline, once a year during routine visits, up to 84 months

2. physician's expectations on therapy

   data on the physician's expectations on systemic therapies (unstandardized questionnaire) will be collected after the physician has enrolled the first patient (FPI) and afterwards annually

   Time frame: at baseline, once a year during routine visits, up to 84 months

3. BRCA mutation testing behavior

   BRCA mutation testing behavior during clinical routine will be assessed with respect to initiator, time of test initiation, type of sample, variants detected, and turnaround time (TAT: duration from request of the BRCA mutation analysis or receipt of the sample in the laboratory, whichever comes later, and the release of the report). Details will be retrospectively assessed for patients with an already existing test result at study inclusion

   Time frame: documented at baseline

4. HRD testing behavior

   HRD testing behavior during clinical routine will be assessed with respect to initiator, type of sample, type of test, HRD status result, HRD score, and turnaround time (TAT: duration from request of HRD analysis or receipt of the sample in the laboratory, whichever comes later, and the release of the report). Details will be retrospectively assessed for patients with an already existing test result at study inclusion.

   Time frame: documented at baseline

5. Safety: Collection of Adverse Events (AE)

   Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness

   Time frame: during routine visits, up to 84 months

6. Patient population

   Patient population described on the basis of: * Baseline characteristics * Disease history * Social status * Comorbidities and concomitant treatments

   Time frame: at baseline and changes at time points of expected routine visits, up to 84 months

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.