SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02408887

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer

Background: - Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: - To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid. Eligibility: - Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body. Design: - Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays. - Participants will: - Answer questions. They may have a tumor biopsy. - Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords. - Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread. - Group 2: have surgery to remove the thyroid and lymph nodes in the neck. - At all post-surgery visits, participants will answer questions and have blood drawn. In addition: - 1 day: laryngoscopy. - 2 weeks: possible laryngoscopy. - 3 months: ultrasound of the thyroid and neck. - Discuss whether to try hormone treatment and/or radioactive iodine. - Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera. - 6 months: ultrasound and maybe laryngoscopy. - 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone. - Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.

NCT02408887 Low-risk Papillary Thyroid Cancer Endocrine Malignancy Thyroid Cancer
MeSH: Thyroid Diseases Thyroid Neoplasms Thyroid Cancer, Papillary
HPO: Abnormality of the thyroid gland Neoplasm of the thyroid gland Thyroid adenoma Thyroid carcinoma Thyroid follicular adenoma

2 Interventions

Name: Total Thyroidectomy (TT)

Description: Total removal of thyroid

Type: Procedure

1 2

Name: Prophylactic central neck lymph node dissection(pCND)

Description: Lymph node dissection

Type: Procedure

1


Primary Outcomes

Description: Proportion of patients that have biochemical cure after totalthyroidectomy (TT) with and without pCND

Measure: Biochemical cure rates undergoing total thyroidectomy (TT) with and without pCND as measured by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 3 months (prior to RAI treatment)

Time: 3 months

Secondary Outcomes

Description: Proportion of patients that have biochemical cure after TT with andwithout pCND

Measure: Biochemical cure rates in patients undergoing total thyroidectomy with and without pCND by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 1 year postoperatively in patients who will not receive RAI or 1 year post remnant ablation

Time: 1 year

Description: Proportion of patients that have improvement in quality of life afterTT with and without pCND

Measure: The QOL of patients

Time: 10 years

Description: Proportion of patients that have improvement in voice quality,swallowing impairment after TT with and without pCND

Measure: Subjective voice quality, swallowing impairment

Time: 6 month

Description: Rate and duration hypoparathyroidism

Measure: Rate and duration of both symptomatic and asymptomatic hypoparathyroidism

Time: 6 month

Description: Proportion of patients that have cervical wound complications

Measure: Rate of cervical wound complications

Time: 3 month

Description: Correlation between BRAF V600E of tumor and median amount of time before disease progression

Measure: Correlation between BRAF V600E of tumor and median amount of time before disease progression

Time: at progression

Description: Proportion of patients that have less neck pain

Measure: Neck pain

Time: 6 month

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Correlation between BRAF V600E of tumor and median amount of time before disease progression. --- V600E ---

but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, NCI or confirmed by the pathology laboratory of the enrolling institution: - Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with BRAF V600E mutation or RET/PTC rearrangement - Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology. --- V600E ---

but less than or equal to 4 cm. in size with either: - inconclusive thyroid cytology positive for BRAF V600E mutation or RET/PTC rearrangement or - cytologically suspicious for or consistent with PTC - Absence of extrathyroidal extension or lymphadenopathy suggesting metastatic PTC on physical examination and neck ultrasound. --- V600E ---



HPO Nodes


HPO:
Abnormality of the thyroid gland
Genes 327
CDKN1A PCSK1 SOX3 CDKN1B GABRD TPO CDKN2B CDKN2C UBR1 IL12A TMEM67 IL12RB1 TREX1 PDE4D ZBTB20 PLVAP TRH STUB1 WDR4 SPIB TRHR MCM8 DNAJC19 MARS USP9X ENPP1 HLA-DRB1 PIEZO1 SLC26A4 ACP5 IQSEC2 GAS1 INSR MC2R GATA1 GATA6 CDH23 IRF5 RPS20 SRY TSC1 TSC2 GCH1 EXT2 TSHB TSHR KEAP1 EYA1 PTCH1 RREB1 PTEN BCOR ADA HNF4A ADAR TRIP13 GDNF ALX4 DDOST STAR HESX1 STAT1 PHF21A STAT3 TBC1D24 HIRA MEN1 NSDHL IFIH1 DACT1 BMP4 MALT1 SAA1 BMPR1A ARL6IP6 KISS1R SALL1 ALMS1 BRAF PROKR2 CLPB CLCNKB PIK3C2A PAX8 HPD PIK3CA FDX2 SGPL1 GLI2 GLI3 JAG1 KCNJ10 RNASEH2C SCN4A UFD1 BUB1 ARNT2 BUB1B VPS13A HRAS DCAF17 C1QBP MLH1 C1S ALG8 FGF8 AKT1 KIAA0556 BCL10 FGFR1 PLCG2 CDC73 GNAS SEMA4A HSD17B3 FOXH1 NODAL EIF2AK3 KDM6A TNFSF15 TRAPPC9 SEC23B TBX1 SDHB SDHC SDHD CDON FOXI1 GP1BB PMM2 TBX2 FOXP3 DUOXA2 FOXE1 PMS1 NPHS1 RNASEH2B KRAS CACNA1C RAG1 RAG2 FLII CACNA1S TCF4 SEMA3C HNF1B DMXL2 PMS2 FBLN5 ADAMTSL1 B3GLCT DEAF1 FMR1 NRAS LHX4 COMT SASH1 SLC25A4 GNE TCOF1 CLIP2 NRTN RNASEH2A WFS1 GPR35 NTRK1 RRM2B POLG EFEMP2 POLR1C WRN IYD KCNAB2 GLIS3 POMC APC SHH AIRE BAZ1B POU1F1 BIRC3 DUOX2 POU2AF1 CASP10 DNM1L CP TWNK NLRP1 CASR POU3F4 SAMHD1 MSH2 CHD7 MSH3 TDGF1 LHX3 AIP IDH1 MINPP1 IDH2 TXNRD2 RET RBM28 APOE RFC2 XRCC4 SIX1 SIX3 GTF2IRD1 ECE1 SKI DLL1 FAS FASLG TF EXOSC2 DICER1 JMJD1C ABCC6 LEP OPA1 LEPR MSTO1 EDN3 EDNRB POLR3A ZIC2 DNAH1 FAN1 TG SLC5A5 TTC7A MST1 RMRP TGFBR2 GPR161 LIFR POLR1D TGIF1 MSH6 RASGRP1 MLXIPL LIG4 SEMA3D LIMK1 KLLN KMT2D MLH3 OTX2 GTF2I MMEL1 THRA THRB SLC12A3 SEC24C LMNA COX1 COX2 COX3 IGH ARVCF WDR11 DCLRE1C SUGCT SLC16A2 NKX2-1 RCBTB1 CCBE1 FANCI BTNL2 PPP1R15B MRAP ND1 SETBP1 ND4 ND5 ND6 PTRH2 PRKAR1A LRP4 FLCN STEAP3 NKX2-5 ROBO1 PRKCD FOXP1 TRNF HABP2 TRNH FUCA1 ELN TRNL1 TRNL2 RERE CTNS GREM1 TRNN LRBA CTNNB1 KCNJ18 IGSF1 TRNQ TANGO2 TRNS1 TRNS2 BUB3 POLG2 FUT8 TRNW KAT6B HBB SUFU CEP57 IL2RA EPCAM PRDM16 IL2RG NNT TNPO3 TBL2 DISP1 RAI1 IL7R PROP1 SEMA3E GABRA3 NIN
Neoplasm of the thyroid gland
Genes 61
FOXE1 CDKN1A PMS1 CDKN1B KRAS CDKN2B CDKN2C TGFBR2 MSH6 RASGRP1 SEMA3D SEMA3C BMPR1A PMS2 KLLN MLH3 NRAS LMNA NRTN PIK3CA NTRK1 SLC26A4 JAG1 KCNJ10 WRN HRAS APC MLH1 PRKAR1A FLCN CASP10 PRKCD AKT1 RPS20 HABP2 MSH2 MSH3 CDC73 KEAP1 GREM1 MINPP1 GNAS SEMA4A RET PTEN ECE1 FAS FASLG EPCAM GDNF DICER1 SEC23B EDN3 EDNRB SDHB SDHC SDHD FOXI1 MEN1 FAN1 TG
Thyroid adenoma
Genes 16
PTEN CDKN1A FAS CDKN1B FASLG PRKAR1A CDKN2B CDKN2C PIK3CA CASP10 PRKCD RASGRP1 AKT1 MSH3 CDC73 MEN1
Thyroid carcinoma
Genes 34
FOXE1 HRAS APC PRKAR1A FLCN CASP10 PRKCD RASGRP1 AKT1 BMPR1A HABP2 KLLN CDC73 KEAP1 GREM1 MINPP1 RET NRAS PTEN FAS FASLG PIK3CA DICER1 NTRK1 SEC23B SLC26A4 JAG1 KCNJ10 SDHB SDHC SDHD FOXI1 TG WRN
Thyroid follicular adenoma