Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)

NCT03735745 | Completed

• 1 other identifier: 102812
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month (at the time of surgery)

Study Arms (5)

Caucasian, HPV positive, Non Smoking patients

EXPERIMENTAL

Blood, tissue and saliva specimen will be collected. Surveys will be administered.

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.

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.

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.

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.

Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys

Interventions

Blood collection OTHER

30cc of blood will be collected.

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 collection OTHER

5cc of saliva will be collected.

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 collection OTHER

Up to 10mg of tissue will be collected.

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

Surveys OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Blood Specimen Collection; Tissue Banks; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Besim Ogretmen, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: January 28, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2022
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)