SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03962647

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Pilot and Feasibility Neoadjuvant Study of a 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.

NCT03962647 Estrogen Receptor-positive Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

2 Interventions

Name: 2-Week Ketogenic Diet

Description: 2-Week Ketogenic Diet in Combination with Letrozole

Type: Dietary Supplement

2-Week Ketogenic Diet

Name: Letrozole

Description: 2.5 mg taken once daily by mouth

Type: Drug

2-Week Ketogenic Diet


Primary Outcomes

Description: The number of patients who complete the dietary intervention, as well as the reasons for early discontinuation and any adverse events will be reported. The number of of cases where pre- and post-treatment samples could be obtained and successfully analyzed for Ki67 and insulin signaling will also be reported.

Measure: Patients who complete the dietary intervention

Time: After 2 weeks of a ketogenic diet

Secondary Outcomes

Description: Measured by Ki67

Measure: Measure enhanced inhibition of cancer cell proliferation

Time: After 2 weeks of a ketogenic diet

Description: Marks of insulin receptor/PI3K pathway activation in tumors

Measure: Reduction in measures of insulin/P13K pathway activation

Time: After 2 weeks of a ketogenic diet

Description: Waist circumference will be measured

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Weight will be checked

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Height will be checked

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Body mass index will be measured

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Fasting glucose/insulin to measure HOMA-IR

Measure: Measure changes in insulin resistance

Time: After 2 weeks of a ketogenic diet

Description: Rate of ketones production

Measure: Measure effectiveness in inducing a ketogenic state

Time: After 2 weeks of a ketogenic diet

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

Reduction in measures of insulin/P13K pathway activation. --- P13K ---



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