Cancer-related Thromboembolic Disease (PROSPECT)
The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.
The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk
The secondary objectives are:
- To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
- To evaluate values of other clotting activation markers in patients with cancer
Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.
Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.
The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yesim DARGAUD, MD PHD
- 전화번호: +33 (0)4 72 11 88 25
- 이메일: ydargaud@univ-lyon1.fr
연구 장소
-
-
-
Bron, 프랑스, 69500
- 모병
- Unité d'Hémostase Clinique Hôpital Louis Pradel
-
연락하다:
- Yesim Dargaud, MD, PhD
- 전화번호: +33 (0)4 72 11 88 25
- 이메일: ydargaud@univ-lyon1.fr
-
수석 연구원:
- Yesim Dargaud, MD, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
- Subjects having signed Informed Consent prior to initiation of any study procedure
- Covered by a Health System
Exclusion Criteria:
- Known bleeding or thrombophilia disorders
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
- Patient immobilized
- Confirmed venous thromboembolism in the last 12 months
- Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
- Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
- Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
- Severe hepatic insufficiency
- Life expectancy of less than 3 months
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
thrombin generation assay results
기간: 7 months
|
7 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Clotting activation markers: thrombin-antithrombin complexes (TAT)
기간: 7 months
|
7 months
|
|
Clotting activation markers: prothrombin fragment F1+2
기간: 7 months
|
7 months
|
|
Clotting activation markers: D-dimer
기간: 7 months
|
7 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
선암종에 대한 임상 시험
-
UNICANCERCanadian Cancer Trials Group완전한
-
Weill Medical College of Cornell UniversityMillennium Pharmaceuticals, Inc.완전한신경내분비성 전립선암 | 소세포 전립선암 | Prostate Adenocarcinoma Plus > 신경내분비 표지자에 대한 50% 면역조직화학적 염색미국
-
Shanghai Zhongshan HospitalShenzhen University General Hospital; Tianjin Cancer Hospital Airport Hospital완전한유방암 | 췌장 선암종(Ductal Adenocarcinoma) | 담도암(담관암종, 담낭암)중국
-
Zhejiang UniversityUTC Therapeutics Inc.모병
Thrombin Generation Assay에 대한 임상 시험
-
Seattle Institute for Biomedical and Clinical ResearchGenomind, LLC완전한
-
ViroGates A/SUniversity of Michigan; The University of Texas Medical Branch, Galveston완전한
-
Taipei Medical University Shuang Ho HospitalWistron Medical Technology Corporation완전한
-
Tianjin Medical University Second Hospital알려지지 않은