Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.
PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.
연구 개요
상태
상세 설명
OBJECTIVES:
Primary
- To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.
Secondary
- To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin [TAT] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
- To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.
OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.
After completion of study, patients are followed up for 3 months.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
DISEASE CHARACTERISTICS:
- Newly diagnosed; relapsed, or refractory multiple myeloma
PATIENT CHARACTERISTICS:
- Central venous access devices allowed
- Recruited by the Division of Hematology/Oncology and the Lineberger Comprehensive Cancer Center at the University of North Carolina
- No history of venous thromboembolism
- No hospitalization for > 2 days within the past month
- Not pregnant
- No patient who refuses or is deemed unsuitable for chemotherapy
PRIOR CONCURRENT THERAPY:
No surgery within the past month
- Bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed
* No concurrent anticoagulation therapy
- Concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Levels of circulating tissue factor (TF)
기간: 5 years
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5 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Alteration in coagulation parameters
기간: 5 years
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5 years
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Correlation of TF with markers of coagulation activation and endothelial activation
기간: 5 years
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5 years
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Incidence of venous thromboembolism
기간: 5 years
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nigel Mackman, PhD, UNC Lineberger Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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