SCOUT-1: Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer

• Sponsor: AstraZeneca (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04830709
• Collaborator: North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.) (Other)
• Enrollment: 750
• Locations: 65
• Anticipated Duration (Months): 126.5
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Jun 15, 2021
• Anticipated Primary Completion Date: Dec 31, 2031
• Anticipated Study Completion Date: Dec 31, 2031

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. progression-free survival (PFS) [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]

   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.

Secondary Outcome Measures

1. 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]

   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

2. Progression-/recurrence-free survival rate [percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years]

   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

3. 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]

   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;

4. 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]

   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

5. 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]

   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

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

   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

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

   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

8. Overall survival (OS) [time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months]

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

9. Patient-reported health-related quality of life (HRQoL) - EQ-5D questionnaire [during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months]

   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).

10. Patient-reported health-related quality of life (HRQoL) - FACT-O questionnaire [during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months]

    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)

11. Patient-reported health-related quality of life (HRQoL) - MOSTv2 questionnaire [during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months]

    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

12. Patient-reported health-related quality of life (HRQoL) - PGI-S questionnaire [during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months]

    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.

Other Outcome Measures

1. Patient's expectations/needs [at baseline, once a year during routine visits, up to 84 months]

   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

2. physician's expectations on therapy [at baseline, once a year during routine visits, up to 84 months]

   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

3. BRCA mutation testing behavior [documented at baseline]

   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

4. HRD testing behavior [documented at baseline]

   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.

5. Safety: Collection of Adverse Events (AE) [during routine visits, up to 84 months]

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

6. Patient population [at baseline and changes at time points of expected routine visits, up to 84 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Aachen		Germany	52074
2	Research Site	Amberg		Germany	92224
3	Research Site	Aschaffenburg		Germany	63739
4	Research Site	Augsburg		Germany	86156
5	Research Site	Baden-Baden		Germany	76532
6	Research Site	Bayreuth		Germany	95445
7	Research Site	Berlin		Germany	10367
8	Research Site	Berlin		Germany	12559
9	Research Site	Berlin		Germany	13353
10	Research Site	Berlin		Germany	13509
11	Research Site	Berlin		Germany	14169
12	Research Site	Bielefeld		Germany	33604
13	Research Site	Bielefeld		Germany	33611
14	Research Site	Bochum		Germany	44791
15	Research Site	Bottrop		Germany	46236
16	Research Site	Brandenburg an der Havel		Germany	14770
17	Research Site	Böblingen		Germany	71032
18	Research Site	Coburg		Germany	96450
19	Research Site	Donauwörth		Germany	86609
20	Research Site	Dortmund		Germany	44137
21	Research Site	Dresden		Germany	0
22	Research Site	Düsseldorf		Germany	40489
23	Research Site	Eggenfelden		Germany	84307
24	Research Site	Fürth		Germany	90766
25	Research Site	Hamburg		Germany	20357
26	Research Site	Hamburg		Germany	22307
27	Research Site	Hamburg		Germany	22457
28	Research Site	Heilbronn		Germany	74078
29	Research Site	Hildesheim		Germany	31134
30	Research Site	Homburg		Germany	66421
31	Research Site	Kiel		Germany	24116
32	Research Site	Krefeld		Germany	47805
33	Research Site	Köln		Germany	50935
34	Research Site	Leipzig		Germany	0
35	Research Site	Limburg		Germany	65549
36	Research Site	Lübeck		Germany	23562
37	Research Site	Magdeburg		Germany	39108
38	Research Site	Magdeburg		Germany	39130
39	Research Site	Mönchengladbach		Germany	41061
40	Research Site	Münster		Germany	48145
41	Research Site	Nürnberg		Germany	90419
42	Research Site	Nürtingen		Germany	72622
43	Research Site	Offenburg		Germany	77654
44	Research Site	Osnabrück		Germany	49076
45	Research Site	Pforzheim		Germany	75179
46	Research Site	Plauen		Germany	0
47	Research Site	Regensburg		Germany	93053
48	Research Site	Rheine		Germany	48431
49	Research Site	Rosenheim		Germany	83022
50	Research Site	Rostock		Germany	18059
51	Research Site	Rotenburg (Wümme)		Germany	27356
52	Research Site	Saarlouis		Germany	66740
53	Research Site	Schwäbisch Hall		Germany	74523
54	Research Site	Siegen		Germany	57072
55	Research Site	Singen		Germany	78224
56	Research Site	Stralsund		Germany	18439
57	Research Site	Stuttgart		Germany	0
58	Research Site	Stuttgart		Germany	70199
59	Research Site	Traunstein		Germany	83278
60	Research Site	Villingen-Schwenningen		Germany	78052
61	Research Site	Wiesbaden		Germany	65199
62	Research Site	Winnenden		Germany	71364
63	Research Site	Witten		Germany	58452
64	Research Site	Wolfsburg		Germany	38440
65	Research Site	Wuppertal		Germany	42283

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT04830709
• Other Study ID Numbers: D0817R00030
• First Posted: Apr 5, 2021
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by AstraZeneca: Patient reported outcome (PRO),; advanced Ovarian Cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Aug 1, 2022