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Study Title and Description

Childhood acute leukemia, maternal beverage intake during pregnancy, and metabolic polymorphisms.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title Childhood acute leukemia, maternal beverage intake during pregnancy, and metabolic polymorphisms.
Author A Bonaventure,J Rudant,S Goujon-Bellec,L Orsi,G Leverger,A Baruchel,Y Bertrand,B Nelken,M Pasquet,G Michel,N Sirvent,P Bordigoni,S Ducassou,X Rialland,D Zelenika,D Hémon,J Clavel,
Country
Year 2013
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 23404349
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? This study analyzed the associations between AL and maternal caffeinated beverage consumption during pregnancy and investigated the influence of NAT2*5 polymorphisms on those relationships. In addition, the influence of CYP2E1*5 and ADH1C*2 alleles on the relationship between AL and maternal alcohol consumption during pregnancy was also assessed.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) The data were generated by the French ESCALE study, which included 764 AL cases and 1,681 controls in 2003–2004. Cases were children diagnosed with AL between 1 January 2003 and 31 December 2004, as defined by the registration criteria of the National Registry of Childhood Hematopoietic Malignancies (NRCH). Age and gender distributions of controls were similar to those of all ESCALE cases. The case and control mothers were interviewed on their consumption habits during pregnancy and nursing using a standardized telephone questionnaire. Genotypes of the candidate alleles (NAT2*5 rs1801280, ADH1C*2 rs698 and rs1693482, CYP2E1*5 rs2031920 and rs3813867) were obtained using high-throughput genotyping and imputation data for 493 AL cases and 549 controls with at least two grandparents born in Europe. Odds ratios (ORs) and their 95 % confidence intervals (95 % CIs) were estimated by unconditional logistic regression models.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) childhood acute leukemia
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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Other
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What is the study design? Case-Control
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description defined by the registration criteria of the National Registry of Childhood Hematopoietic Malignancies (NRCH)
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Coffee cups/day: never/occasionally (reference), regular (>/=1), <1, 1-2, >2
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) gender*age quota variable and several potential confounders (birth order, breastfeeding, maternal educational level, parental socio-professional category, and for the analysis of the whole sample, European ancestry). Odds ratios (OR) and 95 % confidence intervals (CI) estimated by unconditional logistic models including the gender 9 age quota variable, birth order, breastfeeding, maternal education, parental socio-professional category, and European ancestry b OR and 95 % CI estimated by polytomous models of AML and ALL including the gender 9 age quota variable, birth order, breastfeeding, maternal education, parental socio-professional category, and European ancestry
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Provide a general description of results (as reported by the authors). Maternal regular coffee consumption during pregnancy was associated with childhood AL (OR = 1.2 [1.0–1.5], p = 0.02); the odds ratios increased linearly with daily intake (p for trend< 0.001; > 2 cups per day vs. no or less than 1 cup per week: AL: OR = 1.6 [1.2–2.1], lymphoblastic AL: OR = 1.5 [1.1–2.0], myeloblastic AL: OR = 2.4 [1.3–4.3]). The association was slightly more marked for children born to non-smoking mothers. Lymphoblastic AL was also associated with cola soda drinking (OR = 1.3 [1.0–1.5], p = 0.02). No significant gene– environment interactions with coffee, tea, cola soda, or alcohol drinking were observed. For the analyses performed on the whole study sample, the minimum OR that could be detected with a power of at least 80 % and a two-tailed 5 % level of significance, was equal to 1.3 for a prevalence of exposure of 60 %, such as the prevalence of maternal coffee consumption during pregnancy among control mothers.
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Did the authors perform a dose-response analysis (or trend/related analysis)? Yes
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What were the authors's observations re: trend analysis? Coffee selected as most conservative. All AL: LOAEL = 1-2 cups/day; OR = 1.3 (95% CI 1.0-1.7), p </=0.01-0.05 AML: LOAEL = >2 cups/day; OR = 1.5 (1.1, 2.0), p </=0.001-0.01 [note: OR 1.3 (1.0-1.7) for 1-2 cups/day but not marked significant by authors] ALL: LOAEL = >2 cups/day; OR = 2.4 (.3-4.3), p</=0.001-0.01 [note: OR=1.8 (1.0-3.3) for 1-2 cups/day but not marked significant by authors]
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What were the author's conclusions? In conclusion, the present study provides additional evidence that maternal coffee consumption during pregnancy may be associated with an increased risk of childhood AL. The results also suggest a possible role of maternal consumption of cola soda during pregnancy. Caffeinated beverage consumption is a prevalent habit in the general population, and its potential involvement in childhood leukemia needs to be considered further.
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What were the sources of funding? This work was supported by the grants from INSERM, the Fondation de France, the Association pour la Recherche sur le Cancer (ARC), the Agence Franc¸aise de Se´curite´ Sanitaire des Produits de Sante´ (AFSSAPS), the Agence Franc¸aise de Se´curite´ Sanitaire de l’Environnement et du Travail (AFSSET), the association Cent pour sang la vie, the Institut National du Cancer (INCa), the Agence Nationale de la Recherche (ANR), and Cance´ropoˆle Ile de France.
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? Yes
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest). 1-2 cups = 95-190 mg/day >2 cups = >190 mg/day
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  All AL: LOAEL = 95-190 mg/day AML: LOAEL =>190 mg/day ALL: LOAEL = >190 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Coffee selected as most conservative. All AL: LOAEL = 1-2 cups/day; OR = 1.3 (95% CI 1.0-1.7), p </=0.01-0.05 AML: LOAEL = >2 cups/day; OR = 1.5 (1.1, 2.0), p </=0.001-0.01 [note: OR 1.3 (1.0-1.7) for 1-2 cups/day but not marked significant by authors] ALL: LOAEL = >2 cups/day; OR = 2.4 (.3-4.3), p</=0.001-0.01 [note: OR=1.8 (1.0-3.3) for 1-2 cups/day but not marked significant by authors]
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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