Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors

NCT ID: NCT05733091

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2029-12-31

Brief Summary

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To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

Detailed Description

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Objectives:

* To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.
* To estimate the prevalence of health promotion behaviors during skull base tumor survivorship
* To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.
* To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.
* To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.

Conditions

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Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard of Care

Standard of care assessment of their function including pituitary hormone lab draws, audiogram hearing test, eye exam, teeth and jaw exam (in trismus clinic) and speech and swallowing evaluation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.
2. Age ≥ 18 years
3. Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
4. Ability to understand and willingness to sign written informed consent

Exclusion Criteria

1. History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
2. Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
3. Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shirley Su, MBBS

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shirley Su, MBBS

Role: CONTACT

(713) 792-4720

Facility Contacts

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Shirley Su, MBBS

Role: primary

713-792-4720

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2023-01436

Identifier Type: OTHER

Identifier Source: secondary_id

PA18-0969

Identifier Type: -

Identifier Source: org_study_id

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