The Gynecological Cancer Associated Thrombosis (GynCAT) Study

NCT06284343 | Recruiting

• 1 other identifier: 6414
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment, aiming at development and validation of a Risk Assessment Model (RAM) for Venous Thromboembolism (VTE) in this specific population.

Conditions

Cancer-associated Thrombosis; Venous Thromboembolism; Gynecologic Cancer; Ovarian Cancer; Cervix Cancer; Endometrial Cancer; Vaginal Cancer

Keywords

Thrombosis; Venous thromboembolism; Cancer; Ovarian Cancer; Vaginal Cancer; Endometrial Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Venous thromboembolism

  Venous Thromboembolism (VTE) diagnosis will be assigned in case of objective confirmation by venous duplex ultrasonography and/or contrast enhanced CT and/or MRI and/or ventilation/perfusion SPECT. In case of death during follow-up, clinical documentation and/or autopsy findings, if available, will be reviewed to assess for the presence of a possible diagnosis of fatal pulmonary embolism. VTE events will be independently judged by an external committee, constituted by Angiology and Radiology experts, blinded to patients' clinical history and laboratory parameters. Incidentally detected VTE events will be considered as events, provided their eligibility by the aforementioned external committee.

  Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.

Secondary Outcomes (1)

• Number of Participants with Bleeding events (major and clinically relevant non-major bleeding)

  Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.

Study Arms (1)

Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment

Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm

Drug: Anticoagulant

Interventions

Anticoagulant DRUG

Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation

Also known as: Low Molecular Weight Heparin, Apixaban, Rivaroxaban

Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients affected by Gynecologic Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the Thrombosis Clinic of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.

You may qualify if:

• Female sex;
• Diagnosis of gynecologic neoplasm (ovarian, tubal, uterine, cervical, vaginal, vulvar neoplasm);
• Planned new line of systemic antineoplastic treatment;
• Age of 18 years or older;
• Accordance of Informed Consent.

You may not qualify if:

• Pregnant or breastfeeding women;
• Indication to receive therapeutic dose anticoagulant therapy (e.g., atrial fibrillation, mechanical heart valve);
• Diagnosis of symptomatic VTE at the time of screening for enrollment.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Fondazione Umberto Veronesi: collaborator

Study Sites (1)

Agostino Gemelli University Polyclinic Foundation IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Vaginal Neoplasms; Thrombosis; Neoplasms

Interventions

Anticoagulants; Heparin, Low-Molecular-Weight; apixaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; 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; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roberto Pola, PhD; MD

  Agostino Gemelli University Polyclinic Foundation IRCCS

  PRINCIPAL INVESTIGATOR

• Paolo Santini, MD

  Agostino Gemelli University Polyclinic Foundation IRCCS

  STUDY CHAIR

Central Study Contacts

Roberto Pola, PhD; MD

CONTACT

+39 0630157075; roberto.pola@policlinicogemelli.it

Paolo Santini, MD

CONTACT

paolo.santini@guest.policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)