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The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research (SOCQER-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569983
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

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.

Condition or disease Intervention/treatment
Ovarian Neoplasms Other: Observational cohort

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Study Type : Observational
Actual Enrollment : 235 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre Prospective Pilot Observational Cohort Study to Assess Quality of Life and Survival After Surgery for Advanced Ovarian Cancer
Study Start Date : September 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
Observational cohort
Observational study - all suspected or confirmed ovarian cancer patients
Other: Observational cohort
No intervention - observational study




Primary Outcome Measures :
  1. Quality of life [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ovarian cancer patients
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569983


Locations
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United Kingdom
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
Sponsors and Collaborators
University of Birmingham
Investigators
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Study Director: Sudha S Sundar University of Birmingham
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02569983    
Other Study ID Numbers: RG_WM_040
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders