Venous Thromboembolic Complications in Ovarian Cancer

NCT02480790 | Unknown DMC

• 1 other identifier: OV-VTE
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of the study are: To estimate the incidence of venous thromboembolism (VTE) in a cohort of women with suspected ovarian cancer and evaluate changes in the coagulation system in case of benign or malignant disease. The impact of changes in the coagulation system on disease prognosis will be evaluated.

Conditions

Venous Thromboembolism; Ovarian Neoplasms; Ovarian Cancer; Deep Vein Thrombosis; Lung Embolism

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism due to ovarian cancer

  Compressive ultrasound scan of lower extremities and pulmonary CT-angiography

  one year

Secondary Outcomes (2)

• Changes in the coagulation system in case of ovarian cancer

  one year

• Impact of changes in the coagulation system on disease prognosis in ovarian cancer

  one year

Study Arms (2)

Patients with malignant disease

Patients with ovarian, tubar or primary peritoneal cancer

Patients with benign disease

Patients with suspected ovarian cancer where the final pathologic diagnosis is benign

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women referred to the outpatient clinic with suspected ovarian cancer, where the initial examinations with ultrasound scan and measurement of ca-125 in blood reveal a Risk Malignancy Index (RMI) ≥ 200 indicating a high risk of ovarian cancer.

You may qualify if:

• Women referred to the Department of Gynaecology and Obstetrics, Aalborg University Hospital on suspicion of ovarian cancer can be included if they present with a RMI ≥ 200.

You may not qualify if:

• Previous cancer (within previous 3 years) or concomitant cancer of any origin.
• Known immunological connective tissue disease.
• Lack of informed consent.

Sponsors & Collaborators

• Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery: lead

Study Sites (1)

Department of Gynecology and Obstetrics, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and also healthy tissue for comparison are taken at surgery. Blood samples.

MeSH Terms

Conditions

Venous Thromboembolism; Ovarian Neoplasms; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Ole Thorlacius-Ussing, MD, DMSc

  Department of Gastrointestinal Surgery, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2015
• First Posted: June 25, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2019
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

DK (1)