NCT00508170

Brief Summary

Primary Objectives:

  1. 1.To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.
  2. 2.To determine if high-risk sexual behaviors are more common in patients with HPV (human papillomavirus) associated head and neck cancer than those without evidence of HPV-16 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

July 25, 2007

Last Update Submit

July 27, 2012

Conditions

Head and Neck CancerOropharyngeal CancerHuman Papillomavirus Infection

Keywords

Head and Neck CancerHuman Papillomavirus InfectionOropharyngeal PatientsSexual BehaviorQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Number of Responders with High-risk Sexual Behaviors

    Written self-administered questionnaire responses analyzed to determine whether patients with oropharyngeal cancer have history of high-risk sexual behavior (defined as 15 or more lifetime sexual partners) greater than that of patients with tumors of other sites of head and neck

    1 month for mailing and return of questionnaires

Study Arms (2)

Patients with Oropharyngeal Cancer

Behavioral: Questionnaire

Patients with Non-Oropharyngeal Cancer

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete.

Patients with Non-Oropharyngeal CancerPatients with Oropharyngeal Cancer

Eligibility Criteria

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

Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.

You may qualify if:

  • Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
  • Head and Neck cancer participants of LAB00-062 that are still alive.
  • Head and Neck cancer participants of LAB00-062 that have known mailing addresses in the U.S.A.
  • Patients must be 18 years and older.
  • Patients will have completed their primary treatment but may be undergoing treatment for a second primary or recurrent disease.
  • Ability to read, write, and speak Spanish or English.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsOropharyngeal NeoplasmsPapillomavirus InfectionsSexual Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

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

    UT MD 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

July 25, 2007

First Posted

July 27, 2007

Study Start

March 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)