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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation V18M

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.

NCT02522988
Conditions
  1. Fatigue
Interventions
  1. Behavioral: Open-label placebo intervention
MeSH:Fatigue
HPO:Fatigue

If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses. --- Val18Met ---

Primary Outcomes

Description: Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.

Measure: Enrollment Rate

Time: End of Study (7 weeks)

Description: Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.

Measure: Accrual Rate as a Measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number of placebos taken / number prescribed (84)

Measure: Adherence Rate as a Measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number eligible for enrollment / number screened

Measure: Eligibility as a measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled

Measure: Retention as a measure of Acceptability

Time: End of Study (7 weeks)

Secondary Outcomes

Description: Units of measure: units on a scale using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument. 30-questions measure the global, somatic, affective, behavioral and cognitive manifestations of fatigue. Scale for items = 0 (not at all) - 4 (extremely)

Measure: Measure of fatigue manifestation

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Unit of measure: units on a scale using the Medical Outcomes Study 36-Item Short Form (MOS-36) instrument. The 36-item instrument measures the impact of fatigue on vitality, physical functioning, emotional functioning, social functioning and mental health. Scale for items = 1 (limited a lot) - 3 (Not limited at all)

Measure: Measurement of impact of fatigue on quality of life

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.

Measure: Measurement of the impact of fatigue on physical function

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Units of measure: units on a scale using the Fatigue Symptom Inventory (FSI) instrument. Scale = 0 (no fatigue / no interference) to 10 (extreme fatigue / interference)

Measure: Measurement of fatigue severity

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Other Outcomes

Description: Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.

Measure: Test for the presence of a COMT Val158Met/Val or Val/Val variant gene

Time: Baseline


HPO Nodes


HP:0012378: Fatigue
Genes 399
TLL1 SLC25A26 IGH SERPINA6 MEN1 COL1A1 NPM1 ZBTB16 ABCC2 DDB2 KIT SH2B3 IKZF1 MALT1 SOX3 ATM TCF4 HLA-DPA1 GATA6 TP53 SCNN1G NAB2 ALB DCTN1 PROKR2 TGFBR2 NLRP3 IGH TAZ HBA1 GNAS RARA ALAS2 VAPB SLC26A4 MORC2 TXNRD2 NKX2-5 TRAF3 PIK3CA MYD88 MYH6 TSC1 ATRX HLA-DPB1 KCNN4 SLC40A1 PMS2 DUOXA2 COL9A1 SLC22A4 CBL DLST TNPO3 MEN1 TCF3 DNMT3A HESX1 HESX1 AP2S1 PROP1 STAT5B TARDBP DNAJC6 CTLA4 EPAS1 TET2 MRAP MATR3 ERCC3 COL5A1 KCNE1 CDH23 CD46 CCDC78 BCL2 FOXP1 KRAS GLA CHRND PHKG2 NLRP3 PRPH NKX2-1 KIT SLC12A3 PYGM HNF4A NF1 IL12RB1 SDHAF2 SOX3 SLC25A4 PRKAR1A SLC18A2 CALR AIP FAN1 PRTN3 TET2 MDM4 SDHD SLC4A1 POU1F1 LHX4 ATP13A2 NEFH PDE8B HBA2 PREPL GATA2 ERCC2 STAR IYD BRCA1 DNM1L MET PODXL USP8 KIF1B ARNT2 PAX8 SCNN1A CCNF GPR101 C4A HNF1A MAX CCND1 INSR BTK MSH6 PDGFRA MEFV VCP PALLD TBX20 BCL10 TICAM1 TRNK BCL6 NUMA1 PADI4 GATA4 JAK2 KL MSH2 SDHC EIF2AK4 GBA CITED2 LBR HLA-DRB1 PTPN22 ERBB4 TNFSF15 SLC26A4 DAO SDHA CAV3 NLRP3 STAT6 CDC73 HAVCR2 HMGCL PTPN22 FGFR1 DUOX2 SDHB MMEL1 IL10 LRRC8A IL12A-AS1 EPHA4 CHCHD10 CHMP2B PIEZO1 TSHR NNT DMD KIF23 TSC2 TAF15 ERCC4 TSHB COL9A2 IL18BP TNXB IL12A NKX2-5 CD244 OPTN POLG2 SLC11A1 DBH IRF5 XPC SDHB NLRP3 NABP1 PNPLA8 PTPN22 MC2R CFI NAGS CTNNB1 RPS20 GLE1 ACTC1 OTX2 VHL PIGA UNC13A TBK1 CDH23 MYH7 PFN1 SPIB TRHR SLC2A10 PDE11A GLI2 CDH23 IL12B EPCAM XPA PON2 IL10 TBX19 ATP13A2 PLEC WIPF1 COMP SDHD FOXA2 PTPN3 BCOR LHX3 PROP1 PYGL RRM2B HESX1 FIG4 IL12A TWNK UNC93B1 MPL CDKN2A COL1A2 PMS1 CCND1 BRCA2 PROP1 MLX C9ORF72 SMAD3 IGLL1 MST1 TK2 SRSF2 IGHM CD79A PIK3R1 POMGNT1 OPA1 SDHB CD79B IVNS1ABP CFH CITED2 FTL CFAP410 MLH1 FOXE1 IL23R STAT3 PAX8 COQ2 STEAP3 PRKAR1A PON1 HNRNPA1 AGK SMAD4 GCK IGH TFR2 POLG OTX2 FGF23 ATXN2 NR3C1 HLA-B PIGT PGM1 TLR4 LHX4 ARMC5 SEMA4A SDHA BCR IRF2BP2 PALB2 TET2 ASXL1 WAS DMPK ERCC5 POU1F1 RET C1QBP TET2 ATP7A GLT8D1 KCNQ1 CARMIL2 ARMC5 SCNN1B KRAS JAK2 TSHR STAT4 TWNK SMAD3 TG ACADM TMEM127 RUNX1 SLC18A3 ANG TBX20 ANXA11 CCR1 GCH1 MDH2 UBAC2 HFE BIRC3 AIP EPOR PHKA2 BMPR1A MMADHC FAS CPT1A UBQLN2 NLRC4 PSTPIP1 SOX2 PON3 COL9A3 NR3C1 POU2AF1 ERAP1 PRKACA ALB TLR3 CDC73 SLC3A1 TET2 SLC5A5 PML VHL FIP1L1 MLH3 TBK1 ELANE JAK2 NEK1 TBL1XR1 TREM2 FH KLRC4 HLA-B PPARGC1A SQSTM1 HLA-DRB1 NFKB2 MPL VHL SOD1 TPO TLL1 HELLPAR ABL1 SYNJ1 GPR35 CIITA RUNX1 BLNK SLC25A11 FUS RET COL5A2 DYSF SDHC NFKBIL1 BTNL2 HLA-B
Protein Mutations 3
T25W V158M V18M
SNP 0