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Diagnostic Device

Multimodal Optical Imaging for Cervical Dysplasia Detection

N/A

Recruiting

Led By Kathleen Schmeler, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) and not currently breastfeeding

Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test how well a new HPV test detects the virus compared to a current HPV test, as well as how well a new multimodal optical imaging system detects cervical dysplasia.

Who is the study for?

The PEER Trial: Part 2 is for women aged 30-49 with a positive cervical cancer screening test, an intact cervix, and who are not pregnant. Participants must be able to give informed consent. Women under 30 or over 49, those without a cervix due to hysterectomy, or who are pregnant cannot join.Check my eligibility

What is being tested?

This study tests the accuracy of a lateral flow test for HPV against the GeneXpert HPV test and evaluates how well a multimodal optical imaging system detects cervical dysplasia compared to histopathology (tissue examination).See study design

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, typical drug side effects aren't expected. However, there may be discomfort or other minor risks associated with the imaging procedure and sample collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, have a recent negative pregnancy test, and am not breastfeeding.

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I have had a positive test for cervical cancer.

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I am a woman aged between 25 and 49.

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I am a woman with an intact cervix.

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I am willing and able to agree to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of multimodal optical imaging system

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multi-Modal Optical ImagingExperimental Treatment1 Intervention

Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eduardo Mondlane UniversityOTHER

8 Previous Clinical Trials

16,017 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,788,796 Total Patients Enrolled

William Marsh Rice UniversityOTHER

45 Previous Clinical Trials

27,175 Total Patients Enrolled

Media Library

Multimodal Optical Imaging (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05372484 — N/A

Cervical Cancer Research Study Groups: Multi-Modal Optical Imaging

Cervical Cancer Clinical Trial 2023: Multimodal Optical Imaging Highlights & Side Effects. Trial Name: NCT05372484 — N/A

Multimodal Optical Imaging (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05372484 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accommodating geriatric individuals?

"This medical trial requires that applicants are aged between 30 to 49. In contrast, there are 14 trials available for minors and 358 studies offering treatments to seniors."

Answered by AI

How many participants are joining in the research being conducted?

"Yes, this medical study is currently seeking participants. Initial data was posted on March 24th 2021 and recently revised on June 15th 2022. This trial requires 678 individuals from one location to take part."

Answered by AI

What qualifications are necessary for individuals to be eligible for this medical research?

"This trial is looking for 678 patients that have cervical cancer and are aged between 30-49 years old."

Answered by AI

Are there any opportunities to join this clinical endeavor at present?

"Affirmative. Clinicaltrials.gov records verify that this clinical trial is actively recruiting patients, commencing from March 24th 2021 and last updated on June 15th 2022. 678 people are required to take part at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PEER Trial: Part 2 Rice Technologies

2021. "PEER Trial: Part 2 Rice Technologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05372484.