- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02193100
Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center
PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy.
To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients.
연구 개요
상태
정황
상세 설명
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
연구 유형
연락처 및 위치
연구 장소
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40202
- James Graham Brown Cancer Center-University of Louisville
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria for Leukemia Subjects:
- Each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
- Only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
- All patients must have measurable quantities of leukemic blasts on peripheral blood detected with a CBC.
- No history of diabetes for the experimental group or the control group.
- Patients with known hepatitis C or HIV (AIDS) are excluded.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Inclusion Criteria forHealthy Subjects:
- Subjects must have no known prior history of cancer or malignant blood disorders. -Where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. This will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
- Subjects must have WBC, RBC, and platelet counts within normal range on CBC.
- Subjects with known hepatitis C or HIV (AIDS) are excluded.
- No history of Diabetes
- At least 30 years of age
- Preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- None listed in protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
13C-glucose
experimental (13C-glucose)
|
|
No glucose
control (no glucose)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
기간: Baseline up to 6 months post treatment
|
Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.
|
Baseline up to 6 months post treatment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BCC-BMT-13 Leuk Metabolomics
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. .