- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04271215
Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
연구 개요
상세 설명
Data collection Information regarding sex, age at diagnosis, place of residence, white blood cell (WBC) count, immunophenotype (B or T lineage), weight and height (length when appropriate) at diagnosis, and chemotherapy protocol is collected from the patients' clinical charts by previously standardized staff. Overcrowding was used as a proxy for socioeconomic status (SES) according to the Bronfman's criteria (high SES, up to 1.5 people per room; medium-low SES, more than 1.6 people per room). The risk classification is according to the criteria of the National Cancer Institute (NCI): standard risk [ages from 1 to 9.99 years; WBC count < 50 × 109/L] or as high risk [age < 1 or ≥ 10 years or WBC ≥ 50 × 109/L].
Assessment of nutritional status at diagnosis of ALL BMI at diagnosis will be used.. Using WHO software (version 3.2.2, World Health Organization, Geneva), the BMI-for-age Z-scores were calculated for each patient. According to WHO classification, patients were categorized as normal (- 1.9999 to 0.9999), wasted (- 2 to - 2.9999), severely wasted (≥ - 3), at risk of overweight (1-1.9999), overweight (2 to 2.9999) and obesity (≥3). In addition, the BMI percentiles cutoffs provided by CDC were: normal (p5-84.9999), underweight (< p5), overweight (p85-94.9999), and obese (≥ p95). The nutritional classification and measurements validation regarding weight and height recorded in clinical files used to classify patients' nutritional status in present research has been previously described. Underweight patients were excluded from the analyses.
Sample size The sample size calculation was performed using Epi-Info version 7 software taking into account a mortality outcome frequency of 10.8% in the unexposed group (normal weight patients) and a death outcome frequency of 24% for the exposed (obese/overweight patients), a statistical power of 80% and a confidence of 95%; resulting in a total "n" of 350 overweight/obese patients to be compared with the rest of the cohort that are not overweight and obese.
Statistical analysis Descriptive statistics and relative risks (RR) calculation with 95% confidence intervals (CI) will be carried out. Kaplan-Meier survival analysis will be conducted. Log-rank test will be calculated. The analyses will be conducted independently for disease-free-survival (DFS) or overall survival (OS), adjusting for variables whose effects on the studied outcomes have been previously documented (age, sex, socioeconomic status, immunophenotype, NCI risk classification, and chemotherapy protocol). A Cox proportional hazard model will be used. Hazard ratios (HR) with 95% CIs will be calculated.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Mexico City, 멕시코, 02990
- Centro Médico Nacional Hospital General La Raza, IMSS
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Mexico City, 멕시코, 03103
- Hospital General Regional Num 1 Carlos McGregor Sánchez Navarro, IMSS
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Mexico City, 멕시코, 06720
- Hospital de Pediatria "Dr. Silvestre Frenk Freund" CMN Siglo XXI, IMSS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients under 15 years of age
- Newly diagnosed with acute lymphoblastic leukemia
- Diagnosis confirmation by bone marrow aspiration and immunophenotype
- Attended in the participating Hospitals.
Exclusion Criteria:
- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Overweight/Obesity
BMI at diagnosis will be used.
Using WHO software (version 3.2.2,
World Health Organization, Geneva), the BMI-for-age Z-scores were calculated for each patient.
According to WHO classification, patients were categorized as normal (- 1.9999 to 0.9999), wasted (- 2 to - 2.9999), severely wasted (≥ - 3), at risk of overweight (1-1.9999),
overweight (2 to 2.9999) and obesity (≥3).
In addition, the BMI percentiles cutoffs provided by CDC were: normal (p5-84.9999),
underweight (< p5), overweight (p85-94.9999),
and obese (≥ p95).
The nutritional classification and measurements regarding weight and height recorded in clinical files will be used to classify patients' nutritional status in present research has been previously described.
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Chemotherapy protocol used in each participating hospital
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival
기간: year 5
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Deaths of patients occurring during the follow-up period will be collected.
The cause of death and the date that this occurred will be also registered.
In the case of patients alive at the end of follow-up, the date of the last visit to the hospital will be collected.
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year 5
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Disease-free survival
기간: year 5
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Clinical data and by complementary examinations indicating that there is reappearance of the disease after complete remission has been achieved, presence of blasts > 5% in bone marrow (bone marrow relapse) or presence of blasts in cerebrospinal fluid fluid (CNS relapse), testicular infiltration by blasts in the biopsy (testicular relapse), combined (bone marrow/CNS) at any time during treatment .
In case the patient has relapsed, the site of relapse will be collected (bone marrow, CNS, testicle, ovary, eye, etc.).
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year 5
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공동 작업자 및 조사자
수사관
- 수석 연구원: Juan M Mejía-Arangure, PhD, Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- R-2015-785-070
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Chemotherapy protocol used에 대한 임상 시험
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Grupo Espanol Multidisciplinario del Cancer Digestivo모집하지 않고 적극적으로
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Hadassah Medical OrganizationHebrew University of Jerusalem모병
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TC Erciyes University알려지지 않은