Spectroscopy and Artificial Intelligence to Disrupt the Status Quo in Cervical Cancer Screening

NCT05236855 | Unknown

• 1 other identifier: 1026741
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cervical cancer kills one woman every two minutes, 90% of these women are from low- and middle-income countries. Newly developed testing using biofluids has proven successful in identifying disease markers in, for example, brain cancers and endometrial cancers. Early studies have revealed that this technology is also showing potential for gynaecological cancers using validated human papillomavirus (HPV) test specimens. Urine samples, more easily collected, may make screening more accessible and acceptable to women. Spectroscopy is a portable and relatively simple technology; results are instant, reproducible and reliable. Once we confirm that spectroscopy has the ability to identify potential CIN 2+ by detecting HPV in urine, the test can be miniaturized and adapted to a point of care test. This will be more economical and logistically simpler than what is currently available; no consumables and pre-processing of samples are required. Women with abnormal cervical screening and women with normal screening as controls will be recruited, cervical and urine samples will be obtained. These will be tested for HPV DNA using standard methods and also by spectroscopy for HPV. These spectroscopy signals will be analyzed using artificial intelligence. The results will be compared to tissue samples obtained at colposcopy. This will allow evaluation of the new spectroscopy test. This preliminary study aims to prove the concept the spectroscopy as a simple, affordable screen can be used to radically change cervical cancer screening. Enabling a test that has point of care capabilities has huge implications for women in developed and more significantly in low-and middle-income countries, where cervical cytology and HPV testing have significant logistical problems. A non-invasive test will be preferred by many women. We believe spectroscopy will disrupt the status quo of 'no screening' in the low and middle income countries (LMICs), accelerate elimination of cervical cancer, and thus avert 15 million deaths in next 50 years.

Conditions

Cervical Cancer; HPV

Keywords

Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Investigate the ability of spectroscopy to detect high risk HPV in urine

  Confirm detection of HPV in urine using a new technique with I R Spectroscopy

  18 months

Secondary Outcomes (2)

• Measure the concordance between HPV detection by spectroscopy and by a validated HPV DNA test.

  18 months

• Determine the sensitivity and specificity of urine spectroscopy for HPV

  18 months

Study Arms (2)

Intervention

Women seen at the colposcopy clinic at Nova Scotia Health in Gynaecology-Oncology because of an abnormal cervical screen lab report

Diagnostic Test: Spectoscropy testing of urine specimen

Control

Women seen at the General Gynaecology Clinic and the Izaak Walton Killam (IWK) Health Centre with a normal cervical screen lab report

Interventions

Spectoscropy testing of urine specimen DIAGNOSTIC_TEST

Urine samples will be independently tested by I R Spectroscopy and those results are to be compared with standard testing procedures for HPV

Intervention

Eligibility Criteria

• Gender Eligibility Details: Women who undergo standard HPV screening
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing standard HPV screening at the IWK Health Centre and Nova Scotia Health in Halifax, Nova Scotia, Canada

You may qualify if:

• Women undergoing standard HPV screening at the IWK Health Centre and Nova Scotia Health in Halifax, Nova Scotia, Canada

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Society (CCS): collaborator
• Lancaster University: collaborator
• Nova Scotia Health Authority: collaborator

Related Publications (11)

• Paraskevaidi M, Morais CLM, Lima KMG, Snowden JS, Saxon JA, Richardson AMT, Jones M, Mann DMA, Allsop D, Martin-Hirsch PL, Martin FL. Differential diagnosis of Alzheimer's disease using spectrochemical analysis of blood. Proc Natl Acad Sci U S A. 2017 Sep 19;114(38):E7929-E7938. doi: 10.1073/pnas.1701517114. Epub 2017 Sep 5.

  PMID: 28874525 BACKGROUND

• Sargent A, Fletcher S, Bray K, Kitchener HC, Crosbie EJ. Cross-sectional study of HPV testing in self-sampled urine and comparison with matched vaginal and cervical samples in women attending colposcopy for the management of abnormal cervical screening. BMJ Open. 2019 Apr 29;9(4):e025388. doi: 10.1136/bmjopen-2018-025388.

  PMID: 31036707 BACKGROUND

• Pathak N, Dodds J, Zamora J, Khan K. Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. BMJ. 2014 Sep 16;349:g5264. doi: 10.1136/bmj.g5264.

  PMID: 25232064 BACKGROUND

• Ogilvie GS, van Niekerk D, Krajden M, Smith LW, Cook D, Gondara L, Ceballos K, Quinlan D, Lee M, Martin RE, Gentile L, Peacock S, Stuart GCE, Franco EL, Coldman AJ. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. JAMA. 2018 Jul 3;320(1):43-52. doi: 10.1001/jama.2018.7464.

  PMID: 29971397 BACKGROUND

• Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlee F, Franco EL; Canadian Cervical Cancer Screening Trial Study Group. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1579-88. doi: 10.1056/NEJMoa071430.

  PMID: 17942871 BACKGROUND

• Jackson R, Wang L, Jembere N, Murphy J, Kupets R. Why Do Women Get Cervical Cancer in an Organized Screening Program in Canada? J Low Genit Tract Dis. 2019 Jan;23(1):1-6. doi: 10.1097/LGT.0000000000000450.

  PMID: 30489433 BACKGROUND

• Nishri ED, Sheppard AJ, Withrow DR, Marrett LD. Cancer survival among First Nations people of Ontario, Canada (1968-2007). Int J Cancer. 2015 Feb 1;136(3):639-45. doi: 10.1002/ijc.29024. Epub 2014 Jul 9.

  PMID: 24923728 BACKGROUND

• McGahan CE, Linn K, Guno P, Johnson H, Coldman AJ, Spinelli JJ, Caron NR. Cancer in First Nations people living in British Columbia, Canada: an analysis of incidence and survival from 1993 to 2010. Cancer Causes Control. 2017 Oct;28(10):1105-1116. doi: 10.1007/s10552-017-0950-7. Epub 2017 Sep 8.

  PMID: 28887646 BACKGROUND

• Brenner DR, Weir HK, Demers AA, Ellison LF, Louzado C, Shaw A, Turner D, Woods RR, Smith LM; Canadian Cancer Statistics Advisory Committee. Projected estimates of cancer in Canada in 2020. CMAJ. 2020 Mar 2;192(9):E199-E205. doi: 10.1503/cmaj.191292. Epub 2020 Mar 2.

  PMID: 32122974 BACKGROUND

• Organization WH. Global strategy towards eliminating cervical cancer as a public health problem 2020. Available from: https://www.who.int/publications/m/item/draft-global-strategy-towards-eliminating-cervical-cancer-as-a-public-health-problem

  BACKGROUND

• GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018: International Agency for Reserach on Cancer and World Health Organization. Available from: https://gco.iarc.fr/today/data/factsheets/cancers/23-Cervix-Uteri-fact-sheet.pdf.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

urine and cervical samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

James R Bentley, MBChB

CONTACT

902-470-6460; james.bentley@nshealth.ca

Janet L Slaunwhite

CONTACT

902-470-6464; janet.slaunwhite@iwk.nshealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: March 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 11, 2022

Record last verified: 2021-08