SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01999179

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis

The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis.

NCT01999179 Venous Thrombosis Neoplasms
MeSH: Thrombosis Recurrence Venous Thrombosis Postthrombotic Syndrome Postphlebitic Syndrome
HPO: Deep venous thrombosis Venous thrombosis

1 Interventions

Name: Heparin, Low-Molecular-Weight, or direct oral anticoagulants

Description: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot

Type: Drug

low-molecular-weight heparin or direct oral anticoagulant


Primary Outcomes

Description: Recruitment of 56 patients in 1 year and 80% completion of post-thrombotic syndrome assessments by enrolled patients

Measure: Number of cancer patients enrolled with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 1 year

Secondary Outcomes

Description: Obtaining 80% of samples from enrolled patients

Measure: Number of plasma samples obtained for biomarker analysis to predict recurrent venous thrombosis

Time: 1 year

Other Outcomes

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of post-thrombotic syndrome in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

Measure: Incidence of major and clinically relevant non-major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Time: 6 months after catheter removal

Purpose: Health Services Research

Single Group Assignment


There are 2 SNPs

SNPs


1 G20210A

- >18 years of age - Platelet count >50,000 - Creatinine clearance >30 ml/min - Ability to provide informed consent Exclusion Criteria: - Underlying medical condition or chemotherapy requiring long-term anticoagulation - Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations. --- G20210A ---


2 R506Q

- >18 years of age - Platelet count >50,000 - Creatinine clearance >30 ml/min - Ability to provide informed consent Exclusion Criteria: - Underlying medical condition or chemotherapy requiring long-term anticoagulation - Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations. --- G20210A --- --- R506Q ---



HPO Nodes


HPO:
Deep venous thrombosis
Genes 12
THBD F2 PIEZO1 PROC F5 PROS1 SERPIND1 PMM2 SERPINC1 F9 AKT1 PLAT
Venous thrombosis
Genes 74
MPL IL10 JAK2 TET2 IL12A EPOR MET PRSS1 USP8 PRSS2 SAA1 THBD PDE4D PRTN3 THPO HLA-B SPINK1 SH2B3 PDGFRA ERAP1 HLA-DPA1 CALR IL12A-AS1 HLA-DPB1 PIEZO1 CFTR TLR4 CTRC FGA CD55 FGB PRKAR1A AGGF1 CDH23 CPA1 SERPINC1 CASR CCR1 UBAC2 AKT1 PTPN22 PLAT C4A CTLA4 GNAQ IDH1 FGG IDH2 CTNNB1 ACVRL1 PTEN GDF2 FAS F2 HBB ENG F5 CBS SERPIND1 KLRC4 F9 PTH1R MEFV IL23R NOTCH1 PGM1 TP53 STAT4 KIF11 PROC SMAD4 PROS1 PMM2 PIGM