Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs (EASTER)
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ClinicalTrials.gov Identifier: NCT06042543 |
Recruitment Status :
Recruiting
First Posted : September 18, 2023
Last Update Posted : March 8, 2024
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Condition or disease |
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Cervical Cancer Screening |
Study Type : | Observational |
Estimated Enrollment : | 3200 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | A Novel, One Stop, Affordable, Point of Care and Artificial Intelligence Supported System of Screening, Triage and Treatment Selection for Cervical Cancer and Precancer in the Low-to-middle Income Countries |
Actual Study Start Date : | December 9, 2023 |
Estimated Primary Completion Date : | December 31, 2027 |
Estimated Study Completion Date : | December 31, 2027 |
- Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) [ Time Frame: a) Through completion of part 1, an average of 2 years from the start of recruitment; b) Through completion of part 2, an average of 3 years after completion of part 1 ]Participants with histologically confirmed cervical intraepithelial neoplasia grade 2, 3 or cancer, including CIN2 positive for p16.
Biospecimen Retention: Samples With DNA
The women participating in the study will be asked to provide two types of samples at recruitment.
1 ) Urine sample: Women will self-collect 10ml of first-stream Urine using the ColipeeTM collecting device in the clinic. After HPV testing, the leftover samples will be aliquoted and stored at -70C 2) Vaginal self-sampling: Women will self-collect an upper vaginal sample using a dry swab. In the lab, the swab will be washed in 4ml of preservation medium. After HPV testing, the leftover samples will be aliquoted and stored at -70C Stored samples will be used for quality assurance and to address any discordant results between Urine and cervical cell sampling.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- No cervical screening during the previous 3 years
- Between the ages of 25 and 49 years
- Understands and signs a written informed consent form
Exclusion Criteria:
- Refusal to take part for any reason
- Actively menstruating or pregnant
- Treated earlier for cervical precancer or cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042543
Contact: Partha Basu, MD | +33764485370 | basup@iarc.who.int |
Zimbabwe | |
Bothwell Guzha | Recruiting |
Harare, Zimbabwe, 0002 | |
Contact: Bothwell Guzha, MD bothwellguzha@gmail.com |
Principal Investigator: | Partha Basu, MD | International Agency For Research On Cancer (IARC) | |
Principal Investigator: | Bothwell Guzha, MD | University of Zimbabwe | |
Principal Investigator: | Mike Chirenje Zvavahera, MD | University of California, San Francisco | |
Principal Investigator: | Ihtesham U Rehman, PhD | Lancaster University | |
Principal Investigator: | Walter Prendiville, MD | Neo Sense Vector (NSV) |
Responsible Party: | International Agency for Research on Cancer |
ClinicalTrials.gov Identifier: | NCT06042543 |
Other Study ID Numbers: |
IEC 22-32 R37CA275824 ( U.S. NIH Grant/Contract ) |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | March 8, 2024 |
Last Verified: | March 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Uterine Cervical Neoplasms 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 |