The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
SOCQER-2
A Multi-centre Prospective Pilot Observational Cohort Study to Assess Quality of Life and Survival After Surgery for Advanced Ovarian Cancer
1 other identifier
observational
235
1 country
14
Brief Summary
The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated questionnaires in patients undergoing standard or extensive surgery for suspected or confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
14 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
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMay 2, 2019
October 1, 2018
3.3 years
October 5, 2015
May 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life
up to 2 years
Secondary Outcomes (1)
Progression free survival
up to 2 years
Study Arms (1)
Observational cohort
Observational study - all suspected or confirmed ovarian cancer patients
Interventions
Eligibility Criteria
Ovarian cancer patients
You may qualify if:
- Patients with suspected or confirmed ovarian cancer with macroscopic spread beyond the pelvis (FIGO stage III-IV), determined through pre-operative clinical assessment or imaging
- Patient listed for primary debulking surgery or neo-adjuvant chemotherapy with the intent of interval debulking surgery
You may not qualify if:
- Ovarian cancer relapse
- Progression of cancer
- Informed consent not obtained.
- Primary chemotherapy with no intent of interval surgery
- Actively receiving treatment for another cancer
- Secondary cancers \<5years or relapsed secondary cancer in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Ysbyty Gwynedd
Bangor, United Kingdom
Birmingham City Hospital
Birmingham, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Imperial Hospital NHS Trust
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
St Barts and the London
London, United Kingdom
St George's Hospital
London, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
Newcastle Hospitals
Newcastle, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Southend University Hospital
Southend, United Kingdom
Somerset Gynaecological Cancer Centre
Taunton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sudha S Sundar
University of Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
September 1, 2015
Primary Completion
January 1, 2019
Study Completion
April 1, 2019
Last Updated
May 2, 2019
Record last verified: 2018-10