SNPMiner Trials (Home Page)
Report for Mutation V762A
 Developed by Shray Alag, 2020.
SNP Clinical Trial Gene 
There is one clinical trial. 
Clinical Trials
      OPHELIA (OPHELIA (OlaParib and durvalumab in HEad and neck squamous celL carcInomA) trial is
      a Greek, investigator-initiated, randomized open-label window-of-opportunity phase II study.
      Patients with operable histologically documented squamous-cell carcinoma of the oral cavity,
      oropharynx, hypopharynx or larynx will be randomized between combination with durvalumab and
      olaparib, cisplatin and olaparib, monotherapy with olaparib or no treatment, before starting
      standard treatment.
    
Single-nucleotide polymorphisms: PARP-1 Val762Ala. --- Val762Ala --- 
  Primary Outcomes 
 Measure: Investigation of the change in the tumour Ki-67 before and after treatment with the combination of olaparib + durvalumab or olaparib + cisplatin or olaparib monotherapy.
 Time: At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days)
  Secondary Outcomes 
 Measure: Objective response rate according to RECIST 1.1 criteria
 Time: Imaging studies will be performed at baseline and on week 4
 Measure: Pathologic complete response rate
 Time: On week 4 only for operable patients
 Measure: Metabolic response rate assessed by FDG-PET/CT scan (optional)
 Time: At baseline, on week 4
 Measure: Number of participants with tolerability to the treatment.
 Time: From the 1st day of therapy and every week for 4 weeks maximum and 90 days after last therapy administration
 Measure: Surgical complication rate
 Time: Up to 30 days after surgery or the day of initiation of the next anticancer therapy
 Measure: Mutations in genes associated with DNA repair
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: PARP1
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: BRACA1,2
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: ERCC1
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: PDL-1
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: TILs
 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Plasma methylation biomarker: PARP1 methylation in plasma cell-free DNA
 Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: BRCA1,2 methylation in plasma cell-free DNA
 Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: ERCC1 methylation in plasma cell-free DNA
 Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: RAD51C methylation in plasma cell-free DNA
 Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Single-nucleotide polymorphisms: PARP-1 Val762Ala
 Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: ERCC1 Asn118Asn (C/T)
 Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms:ERCC2 Lys751Gln (T/G)
 Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: GSTP1 Ile105Val (A/G)
 Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: XPD Lys751Gln (A/C, C/C)
 Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: XRCC1 Arg399Gln (G/A)
 Time: Sample will be collected once at baseline
 Measure: Circulating tumor cells (CTCs) evaluated for DNA repair biomarkers
 Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Circulating tumor cells (CTCs) evaluated for PD-L1
 Time: At baseline, a day before surgery and 90 days after surgery
HPO Nodes
Squamous cell carcinoma 
Genes 79
COL7A1  WNT10A  CDKN2A  GJB6  FDPS  LZTS1  GTF2H5  TERT  NLRP1  ERCC5  NUTM1  ERCC2  RSPO1  LAMA3  TMC8  CTSC  ING1  RECQL4  GJB2  ERCC2  TGFBR2  ERCC4  LAMC2  LAMB3  MPLKIP  TARS1  ERCC3  XPC  DOCK8  BLM  NTHL1  TYR  PSENEN  WRAP53  GTF2E2  IL7  RNF6  SLC17A9  TNFRSF10B  DKC1  POLH  RECQL4  BLM  BRD4  KRT5  TMC6  TERC  ERCC2  SASH1  WNT10A  MC1R  CIB1  SLC45A2  MVD  WRN  KRT14  DDB2  RNF113A  DCC  FERMT1  TYR  COL7A1  ERCC3  ERCC3  COL7A1  MMP1  COL7A1  GJB2  SLX4  MMP1  LMNA  MVK  TINF2  WWOX  GJB2  OCA2  CIB1  POLH  STAT1   hr>
Carcinoma 
Genes 16
POLE  MSH2  DKC1  SMARCA4  NLRP1  POLD1  CDKN1B  MLH1  RSPO1  FGFR3  BCL10  APC  STK11  PTEN  APC  KIT   hr>