HPV Serum DNA Levels Predicting Outcome in p16+ Squamous... | NCT01984359

Studies
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

NCT01984359

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Apr 10, 2020Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx

Interventions

Obtaining Human tissue

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013Actual

Primary Completion Date

Dec 2015Actual

Completion Date

May 24, 2018Actual

First Submitted Date

Nov 8, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 14, 2013Estimated

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

Apr 9, 2020

Last Update Posted Date

Apr 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Other	Biosamples will be obtained at multiple time-points for all participants	Other: Obtaining Human tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obtaining Human tissue	Other		Single arm

Measure	Description	Time Frame
Number of subjects with Adverse Events		4 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
No or minimal smoking history (\

Accepts Healthy Volunteers

Sex

All

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
Peter Ahn, 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