SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03803553

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer

This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colorectal cancer. The names of the potential treatments involved in this study are: - Active surveillance - FOLFIRI treatment

NCT03803553 Metastatic Colorectal Cancer Stage III Colorectal Cancer
MeSH: Colorectal Neoplasms Colonic Neoplasms
HPO: Colon cancer Neoplasm of the colon Neoplasm of the large intestine

2 Interventions

Name: FOLFIRI Protocol

Description: FOLFIRI, a cycle will be two weeks (14 days) long, with FOLFIRI administered on Days 1-3. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of FOLFIRI chemotherapy.

Type: Drug

ctDNA-POSITIVE: FOLFIRI Protocol

Name: ACTIVE SURVEILLANCE

Description: Will be followed with observation and monitoring with imaging, tumor markers, and ctDNA collections

Type: Other

ctDNA-POSITIVE: ACTIVE SURVEILLANCE ctDNA-NEGATIVE: ACTIVE SURVEILLANCE


Primary Outcomes

Description: Disease-free survival (DFS) between ctDNA-positive patients treated treated with additional adjuvant therapy and ctDNA-positive patients who are untreated

Measure: Disease-free survival (DFS)

Time: 5 years

Description: Compare the clearance rate of ctDNA in ctDNA-positive patients between patients treated with additional adjuvant therapy and those who are untreated

Measure: Clearance rate of ctDNA

Time: 7 Months

Secondary Outcomes

Description: Overall survival (OS) between ctDNA-positive patients treated with additional adjuvant therapy and ctDNA-positive patients who are untreated

Measure: Overall Survival (OS) Rate

Time: 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 G12D

KRAS c.35G>A vs. KRAS G12D). --- G12D ---



HPO Nodes


HPO:
Colon cancer
Genes 39
FOXE1 PMS1 APC MLH1 CDKN2A KRAS PRKAR1A FLCN TGFBR2 MSH6 COL14A1 RPS19 BMPR1A HABP2 PMS2 MSH2 MSH3 MLH3 GREM1 MINPP1 BRCA1 BUB3 BRCA2 CEP57 AAGAB TRIP13 EPCAM PIK3CA PALLD NTHL1 PALB2 MUTYH TP53 AXIN2 SMAD4 BUB1 SH3KBP1 BUB1B FAN1
Neoplasm of the colon
Genes 54
FOXE1 PMS1 CDKN2A KRAS TGFBR2 STK11 MSH6 BMPR1A PMS2 MLH3 BRCA1 BRCA2 PDGFRA PIK3CA POLD1 NTHL1 POLE BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 RPS19 RPS20 HABP2 MSH2 MSH3 GREM1 MINPP1 SEMA4A BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM RNF43 PALLD PALB2 MUTYH SDHA TP53 SDHB SDHC AXIN2 SMAD4 FAN1
Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1