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

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Research Site
  • Amberg, Germany, 92224
    • Recruiting
    • Research Site
  • Aschaffenburg, Germany, 63739
    • Recruiting
    • Research Site
  • Augsburg, Germany, 86156
    • Recruiting
    • Research Site
  • Baden-Baden, Germany, 76532
    • Recruiting
    • Research Site
  • Bayreuth, Germany, 95445
    • Recruiting
    • Research Site
  • Berlin, Germany, 12559
    • Recruiting
    • Research Site
  • Berlin, Germany, 13353
    • Recruiting
    • Research Site
  • Berlin, Germany, 13509
    • Recruiting
    • Research Site
  • Berlin, Germany, 10367
    • Recruiting
    • Research Site
  • Berlin, Germany, 10967
    • Recruiting
    • Research Site
  • Berlin, Germany, 14169
    • Recruiting
    • Research Site
  • Berlin, Germany, 14163
    • Recruiting
    • Research Site
  • Bielefeld, Germany, 33604
    • Recruiting
    • Research Site
  • Bielefeld, Germany, 33611
    • Recruiting
    • Research Site
  • Bochum, Germany, 44791
    • Recruiting
    • Research Site
  • Boeblingen, Germany, 71032
    • Recruiting
    • Research Site
  • Borna, Germany, 4552
    • Recruiting
    • Research Site
  • Bottrop, Germany, 46236
    • Recruiting
    • Research Site
  • Brandenburg an der Havel, Germany, 14770
    • Recruiting
    • Research Site
  • Bremen, Germany, 28205
    • Recruiting
    • Research Site
  • Coburg, Germany, 96450
    • Recruiting
    • Research Site
  • Donauwoerth, Germany, 86609
    • Recruiting
    • Research Site
  • Dortmund, Germany, 44137
    • Recruiting
    • Research Site
  • Dresden, Germany, 1307
    • Recruiting
    • Research Site
  • Duesseldorf, Germany, 40489
    • Recruiting
    • Research Site
  • Eggenfelden, Germany, 84307
    • Recruiting
    • Research Site
  • Erfurt, Germany, 99084
    • Recruiting
    • Research Site
  • Fuerth, Germany, 90766
    • Recruiting
    • Research Site
  • Gera, Germany, 7548
    • Recruiting
    • Research Site
  • Halle, Germany, 6110
    • Recruiting
    • Research Site
  • Hamburg, Germany, 20246
    • Recruiting
    • Research Site
  • Hamburg, Germany, 22307
    • Recruiting
    • Research Site
  • Hamburg, Germany, 22457
    • Recruiting
    • Research Site
  • Hamburg, Germany, 20357
    • Withdrawn
    • Research Site
  • Hanau, Germany, 63450
    • Recruiting
    • Research Site
  • Heilbronn, Germany, 74078
    • Recruiting
    • Research Site
  • Hildesheim, Germany, 31134
    • Recruiting
    • Research Site
  • Homburg, Germany, 66421
    • Recruiting
    • Research Site
  • Jena, Germany, 7747
    • Recruiting
    • Research Site
  • Kiel, Germany, 24116
    • Recruiting
    • Research Site
  • Koeln, Germany, 50931
    • Recruiting
    • Research Site
  • Koeln, Germany, 50935
    • Recruiting
    • Research Site
  • Krefeld, Germany, 47805
    • Recruiting
    • Research Site
  • Leipzig, Germany, 4103
    • Recruiting
    • Research Site
  • Limburg, Germany, 65549
    • Recruiting
    • Research Site
  • Luebeck, Germany, 23562
    • Recruiting
    • Research Site
  • Magdeburg, Germany, 39108
    • Recruiting
    • Research Site
  • Magdeburg, Germany, 39130
    • Recruiting
    • Research Site
  • Mainz, Germany, 55131
    • Recruiting
    • Research Site
  • Moenchengladbach, Germany, 41061
    • Recruiting
    • Research Site
  • Muenster, Germany, 48145
    • Recruiting
    • Research Site
  • Nuernberg, Germany, 90419
    • Recruiting
    • Research Site
  • Nuertingen, Germany, 72622
    • Recruiting
    • Research Site
  • Offenburg, Germany, 77654
    • Recruiting
    • Research Site
  • Osnabrueck, Germany, 49076
    • Recruiting
    • Research Site
  • Pforzheim, Germany, 75179
    • Recruiting
    • Research Site
  • Plauen, Germany
    • Recruiting
    • Research Site
  • Potsdam, Germany, 14467
    • Recruiting
    • Research Site
  • Regensburg, Germany, 93053
    • Recruiting
    • Research Site
  • Rheine, Germany, 48431
    • Recruiting
    • Research Site
  • Rosenheim, Germany, 83022
    • Recruiting
    • Research Site
  • Rostock, Germany, 18059
    • Recruiting
    • Research Site
  • Rotenburg (Wümme), Germany, 27356
    • Recruiting
    • Research Site
  • Saarlouis, Germany, 66740
    • Recruiting
    • Research Site
  • Schwaebisch Hall, Germany, 74523
    • Withdrawn
    • Research Site
  • Siegen, Germany, 57072
    • Recruiting
    • Research Site
  • Singen, Germany, 78224
    • Recruiting
    • Research Site
  • Solingen, Germany, 42653
    • Recruiting
    • Research Site
  • Stendal, Germany, 39576
    • Recruiting
    • Research Site
  • Stralsund, Germany, 18439
    • Recruiting
    • Research Site
  • Stuttgart, Germany, 70199
    • Recruiting
    • Research Site
  • Stuttgart, Germany
    • Recruiting
    • Research Site
  • Torgau, Germany, 4860
    • Recruiting
    • Research Site
  • Traunstein, Germany, 83278
    • Recruiting
    • Research Site
  • Ulm, Germany, 89075
    • Recruiting
    • Research Site
  • Villingen-Schwenningen, Germany, 78052
    • Recruiting
    • Research Site
  • Wiesbaden, Germany, 65199
    • Recruiting
    • Research Site
  • Winnenden, Germany, 71364
    • Recruiting
    • Research Site
  • Witten, Germany, 58452
    • Recruiting
    • Research Site
  • Wolfsburg, Germany, 38440
    • Recruiting
    • Research Site
  • Worms, Germany, 67550
    • Recruiting
    • Research Site
  • Wuppertal, Germany, 42283
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Signed written informed consent
2. Women aged ≥ 18 years
3. Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
4. For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
5. 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
6. 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.
7. Willing and able to report PROs electronically
8. Women of childbearing potential must use two forms of reliable contraception according to standard of care

Exclusion Criteria:

1. 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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	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	percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years
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 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)	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 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 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 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
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 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
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	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
Overall survival (OS)	Overall survival (OS) is defined as time from 1st dose of 1L platinum-based CTX to death of any cause	time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months
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).	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
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)	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
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	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
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.	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline, once a year during routine visits, up to 84 months
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	at baseline, once a year during routine visits, up to 84 months
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	documented at baseline
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.	documented at baseline
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	during routine visits, up to 84 months
Patient population	Patient population described on the basis of: Baseline characteristics; Disease history; Social status; Comorbidities and concomitant treatments	at baseline and changes at time points of expected routine visits, up to 84 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient reported outcome (PRO),; advanced Ovarian Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: D0817R00030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.