Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer

NCT02245100 | Completed DMC

• 3 other identifiers: 14D.1722014-010JT 5957
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in predicting outcomes in patients with stage IV head and neck cancer or stage III-IV non-small cell lung cancer. Studying circulating tumor DNA from patients with head and neck or lung cancer in the laboratory may help doctors predict how well patients will respond to treatment.

Conditions

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Salivary Gland Squamous Cell Carcinoma; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer; Untreated Metastatic Squamous Neck Cancer With Occult Primary

Outcome Measures

Primary Outcomes (1)

• Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)

  To evaluate the predictive value of circulating tumor DNA for DFS/PFS, Cox proportional model will be utilized. Circulating tumor DNA will be treated as either continuous or categorical variables in the regression models. The optimal cut-off value to dichotomize the patients by circulating tumor DNA will be determined by time-dependent receiver operating characteristic curve.

  Up to 2 years

Secondary Outcomes (5)

• Correlation between plasma tumor DNA levels and salivary tumor DNA levels

  Up to 2 years

• Association between absence and presence of circulating tumor DNA mutation with the tumor burden

  Up to 2 years

• Association between absence and presence of circulating tumor DNA mutation with FDG-PET tumor hypermetabolism status

  Up to 2 years

• Correlation between mutations found in plasma and tissue mutations

  Up to 2 years

• Correlation between circulating tumor cells and circulating tumor DNA

  Up to 2 years

Study Arms (1)

Predictive value of circulating DNA

Patients undergo blood sample collection within 1 month before surgery, radiation therapy, or chemotherapy; within 1 week after surgical resection (for patients having upfront surgery); within 1 month before beginning of post-operative radiation therapy (for patients having upfront surgery); during the second week of radiation therapy, during the last week of radiation therapy; and at 1 and 3 months after radiation therapy and then every 3 months for up to 18 months. Patients also undergo saliva sample collection within 1 month before surgery, radiation therapy, chemoradiation therapy, or system chemotherapy and tissue collection at the time of surgery (if upfront surgery is indicated). Blood, saliva, and tissue samples are analyzed for tumor mutations via next generation sequencing.

Other: Cytology specimen; Other: Laboratory biomarker analysis

Interventions

Cytology specimen OTHER

Correlative studies

Also known as: Cytologic sampling

Predictive value of circulating DNA

Laboratory biomarker analysis OTHER

Correlative studies

Predictive value of circulating DNA

Eligibility Criteria

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

Study Population

Patients diagnosed with advanced head and neck carcinoma or NSCLC enrolled at Thomas Jefferson University

You may qualify if:

• Patients older than 18 years age
• Diagnosis of advanced HNC (Stage III, IVA, IVB, IVC) or NSCLC (Stage IIA, IIB, IIIA, IIIB, IV) (patients with synchronous advanced HNC and NSCLC are eligible)
• ECOG performance status score of 0-3
• Life expectancy of 3 months or longer
• Patients able to provide a written informed consent prior to study entry

You may not qualify if:

• Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
• Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin
• Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Jefferson University Hospitals

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, and tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Tongue Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Tongue Diseases

Study Officials

• Voichita Bar-Ad, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 19, 2014
• Study Start: July 22, 2014
• Primary Completion: May 14, 2021
• Study Completion: December 8, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)