A Non-Invasive Cervical Cancer Screening Modality: A Pilo... | NCT02767726

Studies
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

NCT02767726

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Terminated

Last Update Posted

May 13, 2020Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Women With Abnormal Pap Smears

Interventions

non-invasive multimodal imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

May 9, 2016

First Submission Date that Met QC Criteria

May 9, 2016

First Posted Date

May 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Name	Type	Description	Arm Group Labels	Other Names
non-invasive multimodal imaging	Device

Measure	Description	Time Frame
Number of suspicious lesions identified		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
Subjects are 18 years of age or older
Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
Subjects are women.

Exclusion Criteria:

Pregnancy.
Males (males do not have a cervix and thus cannot undergo colposcopy).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danielle Burkland, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided