Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
SCOUT-1
Prospective Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcome Data in Ovarian Cancer Patients Eligible for First-line Platinum-based Chemotherapy and Intended for BRCA/HRD Testing
1 other identifier
observational
750
1 country
93
Brief Summary
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on:
- outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured,
- patient's follow-up (FU) during and after MTX therapy,
- patient-reported outcomes (PROs), experiences and needs,
- physician's experience,
- BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy,
- patient selection for different 1L systemic treatment approaches,
- use and safety of drugs,
- treatment sequence in case of recurrence
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2033
May 22, 2026
May 1, 2026
11.8 years
March 18, 2021
May 21, 2026
Conditions
Keywords
Outcome Measures
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.
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 (12)
Recurrence-free survival (RFS)
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
Progression-/recurrence-free survival rate
percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years
Time to first subsequent therapy (TFST)
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
Second progression-free survival (PFS2)
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
Time to second subsequent therapy (TSST)
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
- +7 more secondary outcomes
Other Outcomes (6)
Patient's expectations/needs
at baseline, once a year during routine visits, up to 84 months
physician's expectations on therapy
at baseline, once a year during routine visits, up to 84 months
BRCA mutation testing behavior
documented at baseline
- +3 more other outcomes
Study Arms (3)
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)
Eligibility Criteria
Approx. 750 patients with newly diagnosed advanced (FIGO stage III or IV) high-grade epithelial ovarian, fallopian-tube, or primary peritoneal cancer are planned to be included in the study in a consecutive manner
You may qualify if:
- Signed written informed consent
- Women aged ≥ 18 years
- Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
- For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
- BRCA mutation test (routinely analyzed germline and/or somatic BRCA1/2 status alone or as part of HRD status determination) already performed or initiated/intended
- First-line platinum-based chemotherapy planned or a maximum of 3 cycles already received with no sign of disease progression. Total number of cycles after enrollment should be decided individually for each single patient by the treating physician. In case of neoadjuvant chemotherapy and interval debulking surgery, the patient should be enrolled after completion of surgical procedure and at the time of the 1st post-surgery cycle of platinum-based chemotherapy.
- Willing and able to report PROs electronically
- Women of childbearing potential must use two forms of reliable contraception according to standard of care
You may not qualify if:
- \. Pregnancy or breast-feeding 2. Current or planned participation in an interventional clinical trial on first-line treatment of OC 3. Current or upcoming systemic treatment of any tumor other than OC 4. Not eligible for platinum-based chemotherapy or early progress during the cycles of first-line platinum-based chemotherapy prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Research Site
Böblingen, Germany, 71032, Germany
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Göttingen, Germany, 37075, Germany
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Nürtingen, Germany, 72622, Germany
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Osnabrück, Germany, 49076, Germany
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Rotenburg (W Mme), Germany, 27356, Germany
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Schwäbisch Hall, Germany, 74523, Germany
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Aachen, 52074, Germany
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Amberg, 92224, Germany
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Aschaffenburg, 63739, Germany
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Augsburg, 86156, Germany
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Baden-Baden, 76532, Germany
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Bayreuth, 95445, Germany
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Berlin, 10367, Germany
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Berlin, 10967, Germany
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Berlin, 12101, Germany
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Berlin, 12559, Germany
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Berlin, 13187, Germany
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Berlin, 13353, Germany
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Berlin, 13509, Germany
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Berlin, 14163, Germany
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Berlin, 14169, Germany
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Bielefeld, 33604, Germany
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Bielefeld, 33611, Germany
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Bochum, 44791, Germany
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Bonn, 53113, Germany
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Borna, 4552, Germany
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Bottrop, 46236, Germany
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Brandenburg an der Havel, 14770, Germany
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Bremen, 28205, Germany
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Coburg, 96450, Germany
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Cologne, 50931, Germany
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Cologne, 50935, Germany
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Dessau, 6947, Germany
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Donauwörth, 86609, Germany
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Dortmund, 44137, Germany
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Dresden, 1307, Germany
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Düsseldorf, 40489, Germany
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Eggenfelden, 84307, Germany
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Erfurt, 99084, Germany
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Fürth, 90766, Germany
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Gelnhausen, 63571, Germany
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Gera, 7548, Germany
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Halle, 6110, Germany
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Hamburg, 20246, Germany
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Hamburg, 20357, Germany
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Hamburg, 22307, Germany
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Hamburg, 22457, Germany
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Hanau, 63450, Germany
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Heilbronn, 74078, Germany
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Hildesheim, 31134, Germany
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Homburg, 66421, Germany
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Itzehoe, 25524, Germany
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Jena, 7747, Germany
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Kiel, 24116, Germany
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Krefeld, 47805, Germany
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Leipzig, 4103, Germany
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Limburg, 65549, Germany
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Lübeck, 23562, Germany
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Magdeburg, 39108, Germany
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Magdeburg, 39130, Germany
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Mainz, 55131, Germany
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Mönchengladbach, 41061, Germany
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Mutlangen, 73557, Germany
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München, 80638, Germany
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Münster, 48145, Germany
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Nuremberg, 90419, Germany
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Offenburg, 77654, Germany
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Pforzheim, 75179, Germany
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Plauen, 08525, Germany
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Potsdam, 14467, Germany
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Recklinghausen, 45659, Germany
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Regensburg, 93053, Germany
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Rheine, 48431, Germany
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Rosenheim, 83022, Germany
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Rostock, 18059, Germany
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Saarlouis, 66740, Germany
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Siegen, 57072, Germany
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Singen, 78224, Germany
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Solingen, 42653, Germany
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Stendal, 39576, Germany
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Stralsund, 18439, Germany
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Stuttgart, 70174, Germany
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Stuttgart, 70199, Germany
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Torgau, 4860, Germany
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Traunstein, 83278, Germany
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Ulm, 89075, Germany
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Villingen-Schwenningen, 78052, Germany
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Wiesbaden, 65199, Germany
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Winnenden, 71364, Germany
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Witten, 58452, Germany
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Wolfsburg, 38440, Germany
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Worms, 67550, Germany
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Wuppertal, 42283, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
April 5, 2021
Study Start
June 15, 2021
Primary Completion (Estimated)
March 31, 2033
Study Completion (Estimated)
March 31, 2033
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.