Head and Neck CancerNCT03735745
Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)
A study testing Blood collection, Saliva collection and Tissue collection in people with Head and Neck Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Blood collection, Saliva collection and Tissue collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age > 18 years
- Ability to sign informed consent
- Newly diagnosed or recurrent oral cavity squamous cell carcinoma of the tongue (stage I-IVa) or oropharyngeal squamous cell carcinoma confirmed by pathology report. Patients with Unknown primary of the neck that is HPV+ are eligible.
- Planning to undergo surgery as a part of definitive treatment
Who cannot join
- Squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site that is HPV negative.
- Already received some treatment, such as chemotherapy, radiation, or surgery for his/her disease at another institution when presenting to MUSC. An exception is neoadjuvant PD-1 blockade.
- History of radiation therapy, for any indication, to the head and neck region
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC)
The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes. Patients will also be given surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by HPV status.
Read the detailed description
The primary objective of this exploratory, proof of concept study is to facilitate translational science spanning clinicians and basic scientists to obtain tissue samples, PDX models, and clinical data in order to successfully analyze tissue linked to clinical outcomes in head and neck cancer, resulting in the methodological and statistical framework for a larger scale clinical trial in the future. While the incidence of HNSCC has been steadily decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer squamous cell carcinoma (OPSCC) and young patients with oral tongue cancer has increased in the face of an overall decline in smoking prevalence. Over the past few years, evidence has emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been described as an "epidemic" and that it has or soon will surpass cervical cancer in both incidence and mortality. In fact, over 30,000 patients will be diagnosed with oropharyngeal cancer in the US per year, making it the most rapidly rising head and neck cancer in incidence. Despite this unique etiopathogenesis, treatment and toxicities related to treatment have not changed. This collaboration and interdisciplinary study will be the first of its kind to address these important issues of cancer site, HPV status, tobacco history, gender, age, and race using both patient tissue and PDX models to identify novel and unique biomarkers. Also, innate to this project is the link between five separate laboratories each conducting unique biomarker analysis.
- Conditions
- Head and Neck Cancer
- Being tested
- Blood collection, Saliva collection, Tissue collection, Surveys
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
30cc of blood will be collected.
Saliva collectionOther
5cc of saliva will be collected.
Tissue collectionOther
Up to 10mg of tissue will be collected.
SurveysOther
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Caucasian, HPV positive, Non Smoking patients | Experimental | Blood, tissue and saliva specimen will be collected. Surveys will be administered. Receives: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys |
| Caucasian, HPV positive, Smoking patients | Experimental | Blood, tissue and saliva specimen will be collected. Surveys will be administered. Receives: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys |
| Newly diagnosed, African American/Black, HPV negative, Smoking | Experimental | Blood, tissue and saliva specimen will be collected. Surveys will be administered. Receives: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys |
| Young (<40 years old), Oral Cavity (Tongue) patients | Experimental | Blood, tissue and saliva specimen will be collected. Surveys will be administered. Receives: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys |
| Neoadjuvant PD-1 Blockade patients | Experimental | Blood, tissue and saliva specimen will be collected. Surveys will be administered. Receives: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of patients who have research blood, saliva and tissue samples collected.
The number of participants to have research blood, saliva and tissues samples collected.
Measured: 1 month (at the time of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start28 Jan 2019
- Primary completion15 Jul 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Besim Ogretmen, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735745
- Sponsor's protocol ID
- 102812
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2018
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC)
- ClinicalTrials.gov ID
- NCT03735745
- Acronym / sponsor ID
- 102812
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Nov 2018 (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.
The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes. Patients will also be given surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by HPV status.
Detailed description
The primary objective of this exploratory, proof of concept study is to facilitate translational science spanning clinicians and basic scientists to obtain tissue samples, PDX models, and clinical data in order to successfully analyze tissue linked to clinical outcomes in head and neck cancer, resulting in the methodological and statistical framework for a larger scale clinical trial in the future. While the incidence of HNSCC has been steadily decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer squamous cell carcinoma (OPSCC) and young patients with oral tongue cancer has increased in the face of an overall decline in smoking prevalence. Over the past few years, evidence has emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been described as an "epidemic" and that it has or soon will surpass cervical cancer in both incidence and mortality. In fact, over 30,000 patients will be diagnosed with oropharyngeal cancer in the US per year, making it the most rapidly rising head and neck cancer in incidence. Despite this unique etiopathogenesis, treatment and toxicities related to treatment have not changed. This collaboration and interdisciplinary study will be the first of its kind to address these important issues of cancer site, HPV status, tobacco history, gender, age, and race using both patient tissue and PDX models to identify novel and unique biomarkers. Also, innate to this project is the link between five separate laboratories each conducting unique biomarker analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Caucasian, HPV positive, Non Smoking patients | Experimental | Other: Blood collection, Other: Saliva collection, Other: Tissue collection, Other: SurveysBlood, tissue and saliva specimen will be collected. Surveys will be administered. |
| Caucasian, HPV positive, Smoking patients | Experimental | Other: Blood collection, Other: Saliva collection, Other: Tissue collection, Other: SurveysBlood, tissue and saliva specimen will be collected. Surveys will be administered. |
| Newly diagnosed, African American/Black, HPV negative, Smoking | Experimental | Other: Blood collection, Other: Saliva collection, Other: Tissue collection, Other: SurveysBlood, tissue and saliva specimen will be collected. Surveys will be administered. |
| Young (<40 years old), Oral Cavity (Tongue) patients | Experimental | Other: Blood collection, Other: Saliva collection, Other: Tissue collection, Other: SurveysBlood, tissue and saliva specimen will be collected. Surveys will be administered. |
| Neoadjuvant PD-1 Blockade patients | Experimental | Other: Blood collection, Other: Saliva collection, Other: Tissue collection, Other: SurveysBlood, tissue and saliva specimen will be collected. Surveys will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Ability to sign informed consent
- Newly diagnosed or recurrent oral cavity squamous cell carcinoma of the tongue (stage I-IVa) or oropharyngeal squamous cell carcinoma confirmed by pathology report. Patients with Unknown primary of the neck that is HPV+ are eligible.
- Planning to undergo surgery as a part of definitive treatment
Key exclusion criteria (3 listed)
- Squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site that is HPV negative.
- Already received some treatment, such as chemotherapy, radiation, or surgery for his/her disease at another institution when presenting to MUSC. An exception is neoadjuvant PD-1 blockade.
- History of radiation therapy, for any indication, to the head and neck region
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 |
|---|---|---|
| Blood collection30cc of blood will be collected. | Other | Caucasian, HPV positive, Non Smoking patients, Caucasian, HPV positive, Smoking patients, Neoadjuvant PD-1 Blockade patients, Newly diagnosed, African American/Black, HPV negative, Smoking, Young (<40 years old), Oral Cavity (Tongue) patients |
| Saliva collection5cc of saliva will be collected. | Other | Caucasian, HPV positive, Non Smoking patients, Caucasian, HPV positive, Smoking patients, Neoadjuvant PD-1 Blockade patients, Newly diagnosed, African American/Black, HPV negative, Smoking, Young (<40 years old), Oral Cavity (Tongue) patients |
| Tissue collectionUp to 10mg of tissue will be collected. | Other | Caucasian, HPV positive, Non Smoking patients, Caucasian, HPV positive, Smoking patients, Neoadjuvant PD-1 Blockade patients, Newly diagnosed, African American/Black, HPV negative, Smoking, Young (<40 years old), Oral Cavity (Tongue) patients |
| SurveysThe Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery. | Other | Caucasian, HPV positive, Non Smoking patients, Caucasian, HPV positive, Smoking patients, Neoadjuvant PD-1 Blockade patients, Newly diagnosed, African American/Black, HPV negative, Smoking, Young (<40 years old), Oral Cavity (Tongue) patients |
Primary outcome
Count of patients who have research blood, saliva and tissue samples collected.
Time frame: 1 month (at the time of surgery)
The number of participants to have research blood, saliva and tissues samples collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Besim Ogretmen, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection, Saliva collection and Tissue collection in people with Head and Neck Cancer, run by Medical University of South Carolina 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: finished, as of the sponsor's last update on 30 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of patients who have research blood, saliva and tissue samples collected. (time frame: 1 month (at the time of surgery)). 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 30 Jan 2025.