TumorsNCT05733091
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
An observational study of Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- 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.
- Age ≥ 18 years
- Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
- Ability to understand and willingness to sign written informed consent
Who cannot join
- History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
- Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
- Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Shirley Su, MBBS, 713-792-4720, sysu@mdanderson.org
Shirley Su, MBBS
About this study
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer
Read the detailed description
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
- Tumors
- Being tested
- Standard of Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) is a disease specific PRO instrument validated for patients with head and neck cancer. It is the most commonly utilized instrument in the head and neck cancer population, of which sinonasal and nasopharyngeal tumors are disease subsites.
Score scale from 0 (symptom has been present) to 10 (the symptom was as bad as you can imagine it could be)
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start20 Dec 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirley Su, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733091
- Sponsor's protocol ID
- PA18-0969
- Other IDs
- NCI-2023-01436
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
- ClinicalTrials.gov ID
- NCT05733091
- Acronym / sponsor ID
- PA18-0969
- Conditions
- Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (4 listed)
- 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.
- Age ≥ 18 years
- Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
- Ability to understand and willingness to sign written informed consent
Key exclusion criteria (3 listed)
- History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
- Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
- Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareStandard 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 | Behavioural | – |
Primary outcome
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
Time frame: through study completion; an average of 1 year
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) is a disease specific PRO instrument validated for patients with head and neck cancer. It is the most commonly utilized instrument in the head and neck cancer population, of which sinonasal and nasopharyngeal tumors are disease subsites. Score scale from 0 (symptom has been present) to 10 (the symptom was as bad as you can imagine it could be)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirley Su, MBBS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Su, MBBS ((713) 792-4720, sysu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.