NCT02569983

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 2, 2019

Status Verified

October 1, 2018

Enrollment Period

3.3 years

First QC Date

October 5, 2015

Last Update Submit

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

Other: Observational cohort

Interventions

No intervention - observational study

Observational cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Birmingham City Hospital

Birmingham, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Imperial Hospital NHS Trust

London, United Kingdom

Location

Royal Marsden Hospital

London, United Kingdom

Location

St Barts and the London

London, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom

Location

Newcastle Hospitals

Newcastle, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

Royal Preston Hospital

Preston, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Southend University Hospital

Southend, United Kingdom

Location

Somerset Gynaecological Cancer Centre

Taunton, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Sudha S Sundar

    University of Birmingham

    STUDY DIRECTOR

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

Locations