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

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03735745
• Other study ID #: 102812
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age > 18 years

2. Ability to sign informed consent

3. 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.

4. Planning to undergo surgery as a part of definitive treatment

Exclusion criteria:

1. Squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site that is HPV negative.

2. 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.

3. History of radiation therapy, for any indication, to the head and neck region

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms

Intervention

Other:
• Blood collection
30cc of blood will be collected.
• Saliva collection
5cc of saliva will be collected.
• Tissue collection
Up to 10mg of tissue will be collected.
• Surveys
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)