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Report for Clinical Trial NCT02408887

Developed by Shray Alag, 2020.
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 Neoplasms Thyroid Cancer, Papillary Thyroid Diseases
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
Group Labels: 2

1 2

Name: Prophylactic central neck lymph node dissection(pCND)

Description: Lymph node dissection
Type: Procedure
Group Labels: 1

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:
HP:0000820: Abnormality of the thyroid gland
Genes 475
SRD5A3 IYD IL2RG GABRA3 ATRX PAX8 IDH2 DMXL2 DUOX2 TNFSF15 GATA1 TCF4 KCNJ10 TWNK RRM2B TTC37 DCLRE1C MC2R ALX4 EXT2 PLCG2 SDHD XRCC4 GABRD FASLG TRNL1 BCL10 BUB1 NKX2-1 TSHR CHD7 FOXP3 FMR1 TSHB LHX4 SETBP1 PDE4D MST1 MALT1 MSTO1 SLC26A4 AIP CDH23 RPS20 GLIS3 BMPR1A SUFU TRNN GNAS TRNL2 PDE4D SUFU FOXP1 TBX1 PIEZO1 ND1 NRAS HBB CLCNKB COX2 EDN3 ZFAT EYA1 GCH1 EIF2AK3 EFEMP2 GLI2 TRAPPC9 PTEN PAX8 SEMA4A HABP2 UFD1 FGF8 PAX8 RNASEH2A LRBA TDGF1 B3GLCT FOXE1 LHX3 TG RET RMRP HRAS TSHR CTNS CASR NKX2-1 TRNQ HSD17B3 EDNRB CDKN2B JMJD1C SGPL1 NKX2-1 PROP1 IFNG THRB FLCN SLC5A5 THRB MLH1 POLG TSHR KCNJ18 KDM6A FUT8 CDKN1A CCBE1 IL12A LIG4 HLA-DRB1 FBLN5 TRNS1 ALMS1 DCLRE1C FOXE1 MSH3 TMEM67 CTNNB1 PAX8 TG POLG2 SEC24C SEMA3E SDHC ZIC2 TNPO3 SLC25A4 LEPR TSHR MMP2 USP9X FOXE1 LEP BIRC3 SDHB WDR4 GDNF LMNA CDKN1B LHX3 TRNL1 TBCK NNT THRA FOXI1 NNT COMT ACP5 POU1F1 SOX3 STAT1 PROKR2 GNAS VPS13A SEMA3D SOX3 TGFBR2 APC LIFR MINPP1 DISP1 CTNS THRB PROP1 SUGCT WDR11 DDOST COX1 TSHR ELN TBX1 PTEN LIG4 TXNRD2 ND5 SIX3 RAG1 ND4 TREX1 SEC23B TSHB CDKN1B RAI1 ADAT3 ELN TPO CEP57 USF3 FOXA2 RREB1 BUB3 SRY IGSF1 PDGFB CDC73 DUOXA2 DEAF1 BCOR FOXI1 PROP1 KLLN HSD17B3 KAT6B FOXP3 NSDHL DLL1 MMP14 WRN GP1BB GLI3 CEP57 BMP4 RFC2 NRTN SRGAP1 CACNA1S KISS1R PPP1R15B STAT3 ND6 CDKN2C TSHR TANGO2 HESX1 RET GPC1 STUB1 HNF1B AKT1 DICER1 TRNF NODAL SLC26A4 DNAJC19 PMM2 DICER1 CTLA4 PRDM16 ITCH GLI2 GNE SKI POLR1D KCNAB2 INSR SLC12A3 ENPP1 WFS1 GLI3 LIMK1 MRAP PTEN TBL2 RNASEH2B TWNK TGIF1 NKX2-5 ZBTB20 POMC TSHR PTEN YY1 DNM1L RERE NKX2-5 MARS1 SCN4A MSH3 ABCC6 IL7R GATA6 GREM1 PRKAR1A ADAMTSL1 POU3F4 EXOSC2 SLC6A17 LEPR KEAP1 CHD7 FUCA1 WFS1 APC IFIH1 HIRA RAI1 AFF4 PIK3C2A RBM28 FGFR1 ARNT2 KMT2D POU2AF1 SMARCB1 CLIP2 SEC23B CACNA1S ALG8 CP MEN1 TPO PPP1R15B PLVAP FAS SIX1 GNAS FANCI BUB1B RET DACT1 HABP2 C1QBP PTRH2 ADAR GAS1 ADA STAT1 SHH STAR IL12RB1 IRF5 FOXH1 TBC1D24 BMPR1A MINPP1 TRHR NKX2-5 POLR1C TRH DNAH1 PMS1 NKX2-1 PIK3CA RAG2 PCSK1 FDX2 GNAS FOXE1 MSTO1 RAI1 MSH6 TF TBX2 FLII FOXE1 TONSL APC STEAP3 BRAF PIK3CA SKIV2L TG HPD POLG LHX4 PROP1 PIK3CA EPCAM FOXD3 TRNS1 KCNJ18 MEN1 IQSEC2 SAA1 KRAS SLC5A5 KAT6B DUOX2 TRIP13 UBR1 SLC26A4 TSC2 IGH AKT1 USP9X ALMS1 PMS2 RCBTB1 APC HBB RASGRP1 CASP10 ROBO1 POU1F1 NPHS1 DMXL2 CDC73 ARVCF GTF2I DUOXA2 TRNW COX3 LHX4 POLR3A PLAA IL2RA CDON PRKAR1A HNF4A RNASEH2C JAG1 BTNL2 TRNH OPA1 DICER1 KIAA0556 NLRP1 TCOF1 APOE GPR35 TBX1 SLC16A2 PRKCD AIRE KCNJ10 HESX1 TRNS2 MLXIPL SAMHD1 TRMT10A LIG4 SEMA3C FMR1 CDH23 TANGO2 TSHR FLCN PTCH1 HESX1 BAZ1B FAN1 CDC73 POU1F1 GPR161 C1S IYD PHF21A MEN1 IDH1 LRP4 DUOX2 RET APC CACNA1C SASH1 PTEN TTC7A OTX2 MSH2 ECE1 APC TRNW MMEL1 SALL1 MCM8 XRCC4 DCAF17 FAS MLH3 SALL1 FOXP1 SPIB NF2 CLPB CDON LHX4 NIN ARL6IP6 GTF2IRD1 SLC26A4 TSC1 PRKAR1A
Protein Mutations 4
F11N K601E V600E V600K
SNP 0