Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03407469

Conditions

Cancer-related Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

Brief summary:

The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer.

This is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.

Conditions

Cancer-related Venous Thromboembolism

Study ID

NCT03407469

Start date

Jan 12, 2018

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult (≥ 18 years) female or male subjects.
2. Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography.
3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis.
4. Intention for long-term treatment (at least 3 months) with anticoagulation.
5. Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation.
6. Able to provide informed consent and complete study survey tools
7. Able to read and speak English.

Exclusion Criteria:

1. Indication for anticoagulation other than cancer-related VTE.
2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.
3. Life expectancy < 3 months.
4. Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT.

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Questionnaires

Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE).

Interventions

Questionnaires

Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE). It should take less than 10 minutes to complete the questionnaires each time.

Primary outcome measure

  • Self-Reported Adherence to Anticoagulation [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Central contacts

Cristhiam M. Rojas Hernandez, MD

713-563-3070cmrojas@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Cristhiam M Rojas Hernandez, MD

cmrojas@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • Questionnaires
  • Surveys
  • Cancer-related Venous Thromboembolism
  • VTE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.