Oral CancerNCT06550050
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
An observational study of Oral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Radiation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 31 Dec 2066
- 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: MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- Pregnant women and/or cognitively-impaired adults are excluded from this study.
- Prior oral squamous cell carcinoma (OSCC) surgery or OSCC radiation treatment at a non-MDA institution.
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
MD Anderson Cancer Center
Houston, Texas, 77030
Xiao Zhao, MD, 713-679-8704, xzhao6@mdanderson.org
Xiao Zhao, MD, (713) 679-8704, xzhao6@mdanderson.org
About this study
Official title: Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes
Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.
Read the detailed description
Primary objectives: Current primary objectives need revision as they focus on diabetes which is not the focus of this study.
- Investigators will examine the role of clinical, environmental, and genetic factors in increasing the risk of developing oral cancers and aggressive oral cancers.
- To identify important environmental and clinical factors contributing to the risk of developing oral cancer or cancer progression
- To identify genetic and molecular factors which contribute to increased risk of developing oral cancers through analysis of germline and somatic genetic alterations
- Investigators will identify clinical and molecular predictors of diagnosis, treatment response, toxicity, and outcomes in patients with oral tumors.
- To identify and validate clinical and molecular prognostic markers that may predict a patient's response to treatment
- To identify and validate clinical and molecular prognostic markers that may predict a patient's risk of developing toxicity related to various modalities of treatment including but not limited to: targeted therapy, chemotherapy, radiation, surgery, and immunotherapy
- To identify and validate clinical and molecular prognostic markers that may predict a patient's prognosis
- To determine whether clinical and treatment factors influence patients' quality of life as assessed by validated self-report instruments routinely incorporated into clinical care pathways
- To identify and validate molecular markers that may improve the diagnosis of oral premalignant or malignant tumors
- To characterize acute and long-term function and quality of life after curative treatment(s)
- Conditions
- Oral Cancer
- Being tested
- Radiation
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationBehavioural
Also called Chemotherapy
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Clinical and molecular features of oral premalignancy and oral cancer | Not described Receives: Behavioral: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92.
Measured: up to 5 years
Secondary outcomes (1)
M.D. Anderson Dysphagia Inventory (MDADI)
The M.D. Anderson Dysphagia Inventory (MDADI) is a written questionnaire to evaluate dysphagia-specific QOL in head and neck cancer patients (Chen, Frankowski et al. 2001). Dysphagia (swallowing difficulty) is a top priority of HNC survivors and a driver of QOL after treatment. The 20-item MDADI questionnaire quantifies an individual's global, physical, emotional, and functional perceptions of his or her swallowing ability. In an internal validation in 100 patients with HNC, concurrent validity was found to be moderate by comparison with the Performance Status Scale (Spearman correlation, 0.47-0.61). Correlation with the physical functional subscale (Spearman correlation, 0.40) and emotional subscale of SF-36 (Spearman correlation, 0.36) demonstrated convergent and divergent validity, respectively, of the MDADI. Test-retest reliability (physical, 0.86; emotional, 0.88; functional, 0.88) and international consistency reliability (overall Cronbach's alpha, 0.96) were sound.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2064 (estimated)
- Study completion31 Dec 2066 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550050
- Sponsor's protocol ID
- 2024-0307
- Other IDs
- NCI-2024-06602
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2024
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes
- ClinicalTrials.gov ID
- NCT06550050
- Acronym / sponsor ID
- 2024-0307
- Conditions
- Oral Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2064 (estimated)
- Study completion
- 31 Dec 2066 (estimated)
- First posted
- 12 Aug 2024 (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.
Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.
Detailed description
Primary objectives: Current primary objectives need revision as they focus on diabetes which is not the focus of this study.
- Investigators will examine the role of clinical, environmental, and genetic factors in increasing the risk of developing oral cancers and aggressive oral cancers.
- To identify important environmental and clinical factors contributing to the risk of developing oral cancer or cancer progression
- To identify genetic and molecular factors which contribute to increased risk of developing oral cancers through analysis of germline and somatic genetic alterations
- Investigators will identify clinical and molecular predictors of diagnosis, treatment response, toxicity, and outcomes in patients with oral tumors.
- To identify and validate clinical and molecular prognostic markers that may predict a patient's response to treatment
- To identify and validate clinical and molecular prognostic markers that may predict a patient's risk of developing toxicity related to various modalities of treatment including but not limited to: targeted therapy, chemotherapy, radiation, surgery, and immunotherapy
- To identify and validate clinical and molecular prognostic markers that may predict a patient's prognosis
- To determine whether clinical and treatment factors influence patients' quality of life as assessed by validated self-report instruments routinely incorporated into clinical care pathways
- To identify and validate molecular markers that may improve the diagnosis of oral premalignant or malignant tumors
- To characterize acute and long-term function and quality of life after curative treatment(s)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical and molecular features of oral premalignancy and oral cancer | – | Behavioral: Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Pregnant women and/or cognitively-impaired adults are excluded from this study.
- Prior oral squamous cell carcinoma (OSCC) surgery or OSCC radiation treatment at a non-MDA institution.
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 |
|---|---|---|
| RadiationAlso: ChemotherapyStandard of care | Behavioural | Clinical and molecular features of oral premalignancy and oral cancer |
Primary outcome
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
Time frame: up to 5 years
The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92.
1 secondary outcome
M.D. Anderson Dysphagia Inventory (MDADI)
Time frame: up to 5 years
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 16 Apr 2026.
- MD 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.
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 Oral Cancer, 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 0 inclusion and 2 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 16 Apr 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 Xiao Zhao, MD ((713) 679-8704, xzhao6@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 for Head and Neck Cancer (MDASI-HN) (time frame: up to 5 years). 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 16 Apr 2026.