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Report for Clinical Trial NCT04077372

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers

The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.

NCT04077372 Gastrointestinal Cancer Colorectal Cancer Pancreatic Adenocarcinoma Gastric Cancer Esophageal Cancer Cholangiocarcinoma Hepatocellular Carcinoma Neuroendocrine Tumors GIST, Malignant
MeSH:Adenocarcinoma Carcinoma, Hepatocellular Neuroendocrine Tumors Cholangiocarcinoma Gastrointestinal Neoplasms Intestinal Neoplasms
HPO:Cholangiocarcinoma Hepatocellular carcinoma Malignant gastrointestinal tract tumors Neoplasm of the gastrointestinal tract Neuroendocrine neoplasm

2 Interventions

Name: Serious Illness Conversation Guide (SICG)

Description: The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients.
Type: Behavioral
Group Labels: 1

Serious illness conversation guide (SICG)

Name: Quality of Life (QOL) survey

Description: Quality of life survey by questionnaire (FACT-G) given every three months
Type: Behavioral
Group Labels: 2

Conversations by treating team Serious illness conversation guide (SICG)


Primary Outcomes

Description: Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms

Measure: Difference in proportions of patients with documented goals of care

Time: 1 year

Secondary Outcomes

Description: Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed.

Measure: Difference in proportions of patients with appropriate care toward end of life

Time: 1 year

Description: Comparison of survey QOL measures by section for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score

Measure: Comparison of QOL survey measures by section

Time: 1 year

Description: Comparison of survey QOL measures overall for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score

Measure: Overall comparison of QOL survey

Time: 1 year

Purpose: Supportive Care

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

- Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy. --- V600E ---



HPO Nodes


HPO:
HP:0007378: Neoplasm of the gastrointestinal tract
Genes 342
DOCK8 CTHRC1 WT1 APC ABCC8 GPC4 PTEN TNFSF15 SMPD1 PRKCD SDHC APPL1 SUFU TCF4 STK11 SMAD7 TTC37 TP53 AHCY POLE H19 RAD51D SDHD RNF43 FASLG CC2D2A SDHC BUB1 PIK3CA TP53 BAP1 ENG SDHD PMS2 CTNNB1 CR2 C11ORF95 PTPN3 PIEZO2 ABCB11 SETBP1 SLC37A4 RELA DAXX MST1 RAD51C SMAD4 FGFR3 PTCH2 SH3KBP1 RPS20 BMPR1A TNFSF12 BMPR1A SMAD4 RAD50 WWOX EP300 SPRTN MSH3 RHBDF2 TP53 FAH GREM1 APC TRIM28 SETBP1 TP53 HNF1A KEAP1 COL14A1 RHBDF2 POLE INS HBB MEN1 NAB2 PMS1 WT1 HFE KRAS EDN3 POLD1 ARSA STAT6 CDKN1C KRAS PTEN PALB2 SEMA4A HABP2 CD81 POU2AF1 TNFSF12 SMAD4 CDH1 IRF1 SEC23B MGMT H19 SDHD IGF2 PDGFRA RET MUTYH NBN MEN1 BRCA2 FAS BRIP1 NFKB2 GNAS RNF6 EDNRB BUB1B CDKN2B DCC TJP2 TP53 PAX4 BUB1B MC1R GCK MDM2 ERBB2 SMAD4 MLH1 STAT1 SRC IL12RB1 IRF5 TNFRSF13C TNFRSF13B ICOS BMPR1A CASP8 INPP5E RAD21 NFKB1 CDKN1A POT1 MINPP1 HNF1A IL12A H19 TRIP13 TMEM67 PMS1 MSH3 PIK3CA KCNQ1 ASCC1 IGF2R BARD1 MLH3 CDK4 SDHC IGF2 MLH1 MSH6 BRCA2 POU6F2 EPCAM ACD TNPO3 APC ATRX PIK3CA SKIV2L PALB2 IL1B MLH1 APC SDHC FOXE1 APC FLCN SDHB PIK3CA EPCAM MEN1 KLF6 TERT SDHB KRAS GDNF LMNA ACVRL1 CTNNB1 CDKN1B CCND1 TRIP13 SDHB DIS3L2 APC STK11 MSH2 AKT1 SLC25A13 BMP2 SDHA GDF2 F5 PMS2 APC APC PTEN IL1RN HBB MITF RASGRP1 CASP10 SMAD4 MRE11 COMP DLEC1 TRIM28 SDHB CHEK2 SDHC BRCA2 BRCA1 SEMA3D DLC1 CHEK2 MSH6 TGFBR2 PIK3CA HFE APC SLC37A4 BLM CDKN2A FH KCNJ11 SLC25A13 JAG1 POLD1 CHEK2 PHKA2 DICER1 PIK3CA HFE MSH2 REST AXIN2 HMBS MS4A1 RPS19 PTEN UROD BMPR1A GPR35 PRKCD JAK2 SDHD SEC23B CTNNB1 CDKN1B AXIN2 HMBS KIT RAD51 TP53 MUTYH SDHB AXIN1 SEMA3C PSAP FGFR2 BMPR1A USF3 TGFBR2 AKT1 PDX1 NTHL1 BUB3 H19-ICR KCNQ1OT1 BLK RPGRIP1L RNF43 NRAS MTOR AAGAB BMPR1A TERF2IP SERPINA1 FAH FAN1 NEUROD1 TGFBR2 MLH1 KLLN GPC3 MSH6 APC G6PC PALLD BCL10 CD19 WRN PTEN KIT GPC3 MSH2 ECE1 CEP57 TREX1 CDKN2B APC PDGFRA KIT MMEL1 NRTN PHKG2 CDKN2A HNF4A KLF11 FAS MET MLH3 BUB1 CASP10 CDKN2C MSH2 SPIB ATP7B PDGFRL PTPRJ AXIN2 AKT1 ENG MUTYH BRCA1 FLCN PTCH1 CEL CDKN2A SDHB MSR1 PRKAR1A
Protein Mutations 5
C10D G12D G12V G34A V600E