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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05733091 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : February 17, 2023 Last Update Posted : February 17, 2023 |
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Brief Summary:
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer
| Tumors | Behavioral: Standard of Care |
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 Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors |
| Actual Study Start Date : | December 20, 2018 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
- Behavioral: 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Probability Sample |
M D Anderson Cancer Center
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05733091
| Contact: Shirley Su, MBBS | (713) 792-4720 | sysu@mdanderson.org |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Contact: Shirley Su, MBBS   713-792-4720   sysu@mdanderson.org   | |
| Principal Investigator: Shirley Su, MBBS Â Â Â Â Â Â | |
M.D. Anderson Cancer Center
| Principal Investigator: | Shirley Su, MBBS | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT05733091 Â Â |
| Other Study ID Numbers: | PA18-0969 NCI-2023-01436 ( Other Identifier: NCI-CTRP Clinical Trials Registry ) |
| First Posted: | February 17, 2023 Â Â Key Record Dates |
| Last Update Posted: | February 17, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Skull Base Neoplasms Skull Neoplasms Bone Neoplasms Neoplasms by Site |
Neoplasms Bone Diseases Musculoskeletal Diseases |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
