RAman For Thyroid cancER
RAFTER
Evaluation of the Role of Vibrational Spectroscopy in the Diagnosis of Premalignant and Malignant Disease of the Thyroid RAFTER (RAman For Thyroid cancER)
3 other identifiers
observational
40
1 country
1
Brief Summary
Ex vivo vibrational spectroscopy (VS), including Raman spectroscopy (RS) of thyroid tissue samples, collected from patients undergoing routine diagnostic thyroid biopsies for diagnosis of potential thyroid cancer. Raman spectra are to be correlated with consensus histopathology and clinical outcomes. Multivariate analysis to be used to evaluate the classification accuracy of VS ex vivo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 26, 2024
February 1, 2024
1 year
July 29, 2019
February 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Test the Raman needle probe on freshly exised tissue
Measure Raman spectra and match with histopathology. Perform leave-one-out analysis to measure performance of diagnosis of Raman spectroscopy
1 year
Secondary Outcomes (1)
Calculate diagnostic performance of Raman spectroscopy probe for thyroid cancer
1 year
Study Arms (5)
Normal benign
participants with normal benign nodules (no cancer)
Follicular thyroid cancer
participants with follicular thyroid cancer
Papillary thyroid cancer
participants with papillary thyroid cancer
Anaplastic thyroid cancer
participants with anaplastic thyroid cancer
Medullary thyroid cancer
participants with medullary thyroid cancer
Interventions
routine surgical removal of thyroid for biopsy
The measurement of Raman spectra from the excised tissue
Eligibility Criteria
Patients attending for routine diagnostic biopsy
You may qualify if:
- Patients undergoing routine diagnostic thyroid biopsy at surgery
You may not qualify if:
- Patients are unable to provide informed consent.
- Patients not attending for standard diagnostic biopsy for thyroid cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biophotonics Research Unit
Gloucester, Gloucestershire, GL1 2AF, United Kingdom
Related Publications (5)
Kamran SC, Marqusee E, Kim MI, Frates MC, Ritner J, Peters H, Benson CB, Doubilet PM, Cibas ES, Barletta J, Cho N, Gawande A, Ruan D, Moore FD Jr, Pou K, Larsen PR, Alexander EK. Thyroid nodule size and prediction of cancer. J Clin Endocrinol Metab. 2013 Feb;98(2):564-70. doi: 10.1210/jc.2012-2968. Epub 2012 Dec 28.
PMID: 23275525BACKGROUNDJenkins CA, Lewis PD, Dunstan PR, Harris DA. Role of Raman spectroscopy and surface enhanced Raman spectroscopy in colorectal cancer. World J Gastrointest Oncol. 2016 May 15;8(5):427-38. doi: 10.4251/wjgo.v8.i5.427.
PMID: 27190582BACKGROUNDFeng X, Moy AJ, Nguyen HTM, Zhang J, Fox MC, Sebastian KR, Reichenberg JS, Markey MK, Tunnell JW. Raman active components of skin cancer. Biomed Opt Express. 2017 May 4;8(6):2835-2850. doi: 10.1364/BOE.8.002835. eCollection 2017 Jun 1.
PMID: 28663910BACKGROUNDCrow P, Barrass B, Kendall C, Hart-Prieto M, Wright M, Persad R, Stone N. The use of Raman spectroscopy to differentiate between different prostatic adenocarcinoma cell lines. Br J Cancer. 2005 Jun 20;92(12):2166-70. doi: 10.1038/sj.bjc.6602638.
PMID: 15928665BACKGROUNDRau JV, Fosca M, Graziani V, Taffon C, Rocchia M, Caricato M, Pozzilli P, Onetti Muda A, Crescenzi A. Proof-of-concept Raman spectroscopy study aimed to differentiate thyroid follicular patterned lesions. Sci Rep. 2017 Nov 2;7(1):14970. doi: 10.1038/s41598-017-14872-1.
PMID: 29097686BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post-Doctoral Research Fellow
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 1, 2019
Study Start
June 1, 2024
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
February 26, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
Pathology reports will be linked using a pseudo-anonymous unique study identifier