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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

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 465
UBR1 PTEN CLPB TBC1D24 BIRC3 HNF1B TMEM67 BCOR OPA1 RAI1 TRNL1 MMP2 NNT LHX4 SLC16A2 POU2AF1 IQSEC2 TGIF1 GREM1 TREX1 CDON POU1F1 WDR11 DICER1 SALL1 PROKR2 RASGRP1 PAX8 DNAH1 NSDHL XRCC4 SDHD PRKCD LRP4 PTRH2 LEPR RET IYD PCSK1 KEAP1 DICER1 FOXI1 POLG PMM2 FGF8 MARS1 ENPP1 CDKN2C GPC1 TSHR DISP1 TSHR GLI3 FOXE1 FOXA2 TBX1 NKX2-1 EYA1 ALG8 HIRA CEP57 MLXIPL HSD17B3 CDH23 LEP CLIP2 TRNF MSTO1 LHX3 BUB1B FLCN PDE4D SEMA3C LIG4 PAX8 GLI2 TRAPPC9 MEN1 IFIH1 SRGAP1 CTLA4 DUOX2 KISS1R KCNJ18 PTEN TBL2 ALMS1 ROBO1 AIP MINPP1 DCAF17 BMPR1A FANCI SPIB PIK3C2A ARVCF MC2R MST1 SEC24C TG IL2RG SUFU HESX1 GNAS THRB KCNJ10 JMJD1C IL12RB1 MEN1 TRNS1 ND5 MMEL1 SEMA3D COMT TSHR TSHR SUFU LIFR SKI STAT3 APC TRNL2 TTC37 INSR GTF2I TDGF1 NRTN TXNRD2 TWNK FOXP1 TBX2 SMARCB1 TRNH PMS2 IDH1 PROP1 PRDM16 IYD LHX4 GNAS NNT TSHR PAX8 DLL1 SLC26A4 TRNL1 NKX2-1 GNAS SLC5A5 LRBA POLG TSHR GABRD GP1BB SIX3 POLR3A POU1F1 SKIV2L VPS13A KRAS NODAL GNAS XRCC4 MSH2 GATA6 IGSF1 CHD7 SEMA3E EDNRB TTC7A NRAS DDOST SLC26A4 DUOXA2 TRNS1 CACNA1S TSHB RAI1 CDKN1A RPS20 KCNJ18 SRD5A3 FOXP3 FBLN5 TRH TPO HPD GPR161 KAT6B FGFR1 COX1 THRB SAA1 STAR MRAP EDN3 NKX2-5 SCN4A FOXE1 CDC73 TG TRNW COX3 EFEMP2 RREB1 FOXE1 TSHR LHX4 NKX2-5 IL12A RNASEH2A DICER1 TGFBR2 NKX2-5 COX2 PAX8 MINPP1 FAS APC LIG4 DUOX2 POLR1D USP9X GLI3 RRM2B FMR1 PLAA C1S SASH1 BTNL2 SEC23B NLRP1 HRAS NKX2-1 NIN GABRA3 ADA TCOF1 FASLG ZFAT CDC73 CLCNKB PROP1 THRB RMRP APC SLC5A5 PRKAR1A FOXI1 RCBTB1 BCL10 BAZ1B APC LIG4 OTX2 WFS1 POU3F4 GAS1 HSD17B3 ND4 RFC2 RERE DACT1 MSH3 PIK3CA MMP14 THRA SLC26A4 ALX4 IDH2 FAN1 TWNK TRNQ TBX1 MSH3 GTF2IRD1 RAI1 CDKN2B PROP1 HESX1 TRNN C1QBP ARNT2 RET CDON CCBE1 CDH23 TNFSF15 RBM28 BRAF IFNG SOX3 SUGCT ITCH BMP4 PRKAR1A GPR35 STAT1 CTNS CASP10 CACNA1C LHX3 TRIP13 B3GLCT JAG1 KIAA0556 DEAF1 KDM6A TSC1 CTNNB1 PTEN FUCA1 ELN GLIS3 PLVAP FLCN KMT2D PTCH1 SIX1 BUB3 TSC1 RET LEPR PLCG2 SLC25A4 FUT8 EXOSC2 DNM1L PDGFB WFS1 POU1F1 ELN SRY MLH3 ND6 DUOXA2 SETBP1 STEAP3 FOXH1 TG DMXL2 HNF4A KAT6B UFD1 FMR1 EIF2AK3 PMS1 TNPO3 ECE1 CACNA1S TSC2 APOE AKT1 SGPL1 WDR4 RAG1 SDHC MLH1 MCM8 LMNA TF POLG2 EXT2 TSC2 NF2 BUB1 PIEZO1 FOXP3 PPP1R15B MSH6 RET APC HABP2 KCNJ10 FOXD3 LHX4 GLI2 CASR ZIC2 TRNW ARL6IP6 DCLRE1C FAS HESX1 TRNS2 IL7R STUB1 PRKAR1A POLR1C NPHS1 PIK3CA POMC ALMS1 FOXE1 LIMK1 TSHB RNASEH2B GNE STAT1 GDNF AIRE APC PDE4D SHH AKT1 TPO IL2RA HLA-DRB1 PROP1 FDX2 TRHR ACP5 SOX3 SLC12A3 HABP2 CDC73 DNAJC19 ND1 CDKN1B CHD7 IGH ADAR SLC26A4 MEN1 FOXE1 RNASEH2C TANGO2 EPCAM NKX2-1 TCF4 KLLN ADAMTSL1 SEC23B SEMA4A ZBTB20 PIK3CA GCH1 FLII RAG2 BMPR1A HBB USP9X ABCC6 SALL1 CTNS WRN PTEN MALT1 PTEN SDHB KCNAB2 MSTO1 DUOX2 CEP57 IRF5 CP TBX1 CDKN1B TSHR GATA1 TONSL SAMHD1 PHF21A ATRX DCLRE1C
Neoplasm of the thyroid gland
Genes 91
ECE1 CASP10 NRTN PTEN JAG1 AKT1 SDHC PTEN MLH1 HABP2 PMS2 APC CDC73 EDN3 LMNA FLCN CDKN1B SEMA3C CDC73 TG GREM1 SLC26A4 DICER1 MSH3 MSH6 RET GNAS APC HABP2 PIK3CA RASGRP1 KCNJ10 EPCAM RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN TGFBR2 SEMA4A PIK3CA FAN1 MINPP1 FAS RET MINPP1 APC MSH3 BMPR1A FAS KRAS CDKN2B KEAP1 DICER1 MSH2 FOXI1 BMPR1A EDNRB PRKAR1A NRAS MLH3 SEC23B WRN PTEN HRAS PTEN SLC26A4 CDKN2C RET PIK3CA NKX2-1 FOXE1 SDHB KCNJ10 FASLG MEN1 CDKN1A RPS20 CDC73 SEMA3D PRKAR1A FOXE1 CDKN1B GDNF PMS1 APC AKT1 APC FOXI1
Thyroid adenoma
Genes 19
CDKN1B FAS CASP10 CDC73 MSH3 FAS FASLG CDKN2B MEN1 CDKN1A AKT1 MSH3 PIK3CA RASGRP1 PRKAR1A PTEN CDKN1B PRKCD CDKN2C
Thyroid carcinoma
Genes 53
CASP10 JAG1 SDHC HABP2 APC CDC73 FLCN TG GREM1 SLC26A4 DICER1 APC HABP2 RASGRP1 KCNJ10 RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN PIK3CA MINPP1 FAS RET MINPP1 APC FAS KEAP1 DICER1 FOXI1 BMPR1A PRKAR1A NRAS SEC23B WRN PTEN HRAS SLC26A4 RET NKX2-1 FOXE1 SDHB KCNJ10 FASLG CDC73 PRKAR1A FOXE1 APC AKT1 APC FOXI1
Thyroid follicular adenoma