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Ovarian CancerSCOUT-1NCT04830709

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

An observational study of Ovarian Cancer, run by AstraZeneca at 89 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 130 years, women only
Conditions the study is for
Ovarian Cancer
How many people
752 participants
Where
89 sitesGermany
Study dates
15 Jun 2021to 31 Mar 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
  • -

Trial locations and contacts

89 sites in 1 country.

89 sites in 1 country

Germany89 sites

  • Research Site

    Aachen, 52074

  • Research Site

    Amberg, 92224

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Augsburg, 86156

  • Research Site

    Bayreuth, 95445

  • Research Site

    Berlin, 10367

  • Research Site

    Berlin, 10967

  • Research Site

    Berlin, 12101

  • Research Site

    Berlin, 12559

  • Research Site

    Berlin, 13187

  • Research Site

    Berlin, 13353

  • Research Site

    Berlin, 13509

  • Research Site

    Berlin, 14163

  • Research Site

    Berlin, 14169

  • Research Site

    Bielefeld, 33604

  • Research Site

    Bielefeld, 33611

  • Research Site

    Böblingen, Germany, 71032

  • Research Site

    Bochum, 44791

  • Research Site

    Bonn, 53113

  • Research Site

    Borna, 4552

  • Research Site

    Bottrop, 46236

  • Research Site

    Brandenburg an der Havel, 14770

  • Research Site

    Bremen, 28205

  • Research Site

    Coburg, 96450

  • Research Site

    Cologne, 50931

  • Research Site

    Cologne, 50935

  • Research Site

    Dessau, 6947

  • Research Site

    Dortmund, 44137

  • Research Site

    Dresden, 1307

  • Research Site

    Düsseldorf, 40489

  • Research Site

    Eggenfelden, 84307

  • Research Site

    Erfurt, 99084

  • Research Site

    Fürth, 90766

  • Research Site

    Gelnhausen, 63571

  • Research Site

    Gera, 7548

  • Research Site

    Göttingen, Germany, 37075

  • Research Site

    Halle, 6110

  • Research Site

    Hamburg, 20246

  • Research Site

    Hamburg, 22307

  • Research Site

    Hamburg, 22457

  • Research Site

    Hanau, 63450

  • Research Site

    Heilbronn, 74078

  • Research Site

    Hildesheim, 31134

  • Research Site

    Homburg, 66421

  • Research Site

    Itzehoe, 25524

  • Research Site

    Jena, 7747

  • Research Site

    Kiel, 24116

  • Research Site

    Krefeld, 47805

  • Research Site

    Leipzig, 4103

  • Research Site

    Limburg, 65549

  • Research Site

    Lübeck, 23562

  • Research Site

    Magdeburg, 39108

  • Research Site

    Magdeburg, 39130

  • Research Site

    Mainz, 55131

  • Research Site

    Mönchengladbach, 41061

  • Research Site

    München, 80638

  • Research Site

    Münster, 48145

  • Research Site

    Mutlangen, 73557

  • Research Site

    Nuremberg, 90419

  • Research Site

    Nürtingen, Germany, 72622

  • Research Site

    Offenburg, 77654

  • Research Site

    Osnabrück, Germany, 49076

  • Research Site

    Pforzheim, 75179

  • Research Site

    Plauen, 08525

  • Research Site

    Potsdam, 14467

  • Research Site

    Recklinghausen, 45659

  • Research Site

    Regensburg, 93053

  • Research Site

    Rheine, 48431

  • Research Site

    Rosenheim, 83022

  • Research Site

    Rostock, 18059

  • Research Site

    Rotenburg (Wümme), Germany, 27356

  • Research Site

    Saarlouis, 66740

  • Research Site

    Siegen, 57072

  • Research Site

    Singen, 78224

  • Research Site

    Solingen, 42653

  • Research Site

    Stendal, 39576

  • Research Site

    Stralsund, 18439

  • Research Site

    Stuttgart, 70174

  • Research Site

    Stuttgart, 70199

  • Research Site

    Torgau, 4860

  • Research Site

    Traunstein, 83278

  • Research Site

    Ulm, 89075

  • Research Site

    Villingen-Schwenningen, 78052

  • Research Site

    Wiesbaden, 65199

  • Research Site

    Winnenden, 71364

  • Research Site

    Witten, 58452

  • Research Site

    Wolfsburg, 38440

  • Research Site

    Worms, 67550

  • Research Site

    Wuppertal, 42283

Other trials in Germany

About this study

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

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
Conditions
Ovarian Cancer
Keywords
Patient reported outcome (PRO),, advanced Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04830709
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  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

    Measured: 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

    Measured: 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;

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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).

    Measured: 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)

    Measured: 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

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start15 Jun 2021
  3. Primary completion31 Mar 2033 (estimated)
  4. Study completion31 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04830709
Sponsor's protocol ID
D0817R00030
Acronym
SCOUT-1
Status last verified
Oct 2026
First submitted
18 Mar 2021
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by AstraZeneca at 89 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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