NCT00662662

Brief Summary

The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

14.2 years

First QC Date

April 17, 2008

Last Update Submit

December 29, 2020

Conditions

Keywords

Oropharyngeal CancerNon-Oropharyngeal CancerHead and Neck CancerSquamous Cell CarcinomaSquamous cell carcinoma of the head and neckSCCHNHPV-16QuestionnaireSexual BehaviorSurvey

Outcome Measures

Primary Outcomes (1)

  • To find out if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16).

    6 Years

Study Arms (2)

Oropharyngeal Cancer

Behavioral: Questionnaire

Non-Oropharyngeal Cancer

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Non-Oropharyngeal CancerOropharyngeal Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.

You may qualify if:

  • Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.
  • Must have the ability to understand and provide informed consent.
  • Patients must be 18 years and older.
  • Ability to read, write, and speak English.
  • Resident of the United States.
  • Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested.

You may not qualify if:

  • Previous cancer diagnosis excluding non-melanoma skin cancer.
  • Blood transfusion within the previous 6 months.
  • Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Oropharyngeal NeoplasmsHead and Neck NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and NeckSexual Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Erich Sturgis, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations