SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02463383

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Alcohol-related Breast Cancer in Postmenopausal Women - Effect of PPARG2pro12ala Polymorphism on Female Sex-hormone Levels and Interaction With Alcohol Consumption and NSAID Usage

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

NCT02463383 Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

2 Interventions

Name: Ibuprofen Tab 400 MG

Description: 400mg ibuprofen is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

Type: Drug

Sequence 1 Sequence 2

Name: Placebo tab

Description: A placebo tablet is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

Type: Drug

Sequence 1 Sequence 2

Primary Outcomes

Description: Plasma estrone sulfate concentration after acute ethanol intake by Ibuprofen intake and/or PPARG genotype

Measure: Serum estrone sulphate (pmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Secondary Outcomes

Description: Plasma estrone decrease after acute ethanol intake by ibuprofen intake and/or PPARG genotype

Measure: Serum estrone (pmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: Plasma SHBG concentration after acute ethanol ingestion by ibuprofen intake and/or PPARG genotype

Measure: Serum SHBG (nmol/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: Plasma ethanol concentration after acute ethanol ingestion

Measure: Serum ethanol (g/l)

Time: from 40 min before to 90 min after alcohol consumption

Description: The plasma metabolome profile by time after alcohol intake

Measure: Serum metabolomics (relative metabolite intensity)

Time: from 40 min before to 24h after alcohol intake

Description: The urine metabolome profile by time after alcohol intake

Measure: Urine metabolomics (relative metabolite intensity)

Time: from 40 min before to 24h after alcohol intake
Purpose: Basic Science

Allocation: Randomized

Crossover Assignment

There is one SNP

SNPs

1 P12A

cholesterol lowering medicine); 7. being allergic to alcohol and/or Ibuprofen 8. smoking Breast Cancer Breast Neoplasms In a pilot human intervention trial we aimed to determine the effect of the PPARG Pro12Ala polymorphism and the PPARĪ³ stimulator, Ibuprofen, on sex-hormone levels following alcohol intake in postmenopausal women. --- Pro12Ala ---

Seven women with PPARG Pro12Ala and 18 PPARG wildtype women were included.The study was performed as a randomised, double-blinded, placebo controlled 2x24 h crossover study. --- Pro12Ala ---


HPO Nodes

HPO:
Breast carcinoma
Genes 51
RAD51 RAD51C RAD51D CDKN2A KRAS MRE11 SLC22A18 STK11 MSH6 KLLN BRIP1 BRCA1 ATR BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 WRN CHEK2 APC BARD1 MLH1 NBN COL14A1 AKT1 PRKN MSH2 FGFR2 IDH1 IDH2 CTNNB1 RB1CC1 PTEN MDM2 AAGAB CDH1 RNF43 PALLD PALB2 OPCML SEC23B TP53 SDHB SDHC SDHD SMAD4 TWIST1 RAD50
Neoplasm of the breast
Genes 73
RAD51 RAD51C RAD51D CDKN2A KRAS CDKN2B CDKN2D MRE11 SLC22A18 STK11 MSH6 RASGRP1 KLLN BRIP1 MGMT BRCA1 LMNA ATR ACD BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 POT1 MC1R MITF WRN CHEK2 APC BARD1 MLH1 PRKAR1A CASP10 NBN PRKCD COL14A1 AKT1 C11ORF95 PRKN RELA MSH2 FGFR2 IDH1 GNAS IDH2 CTNNB1 RB1CC1 PTEN MDM2 FAS FASLG AAGAB CDH1 TERT RNF43 PALLD PALB2 OPCML TERF2IP PRLR SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 TWIST1 RAD50