A Pilot Study to Evaluate the Predictive Value of Circulating Tumor DNA for Clinical Outcome in Patients With Advanced Head and Neck and Lung Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)
Study Overview
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the predictive value of the circulating tumor DNA for disease-free survival/progression-free survival in patients with advanced head and neck carcinoma (HNC) and non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To correlate the levels of plasma tumor DNA with the salivary tumor DNA. II. To correlate the mutations found in the circulating tumor DNA with the mutations in the tumor tissues.
III. To evaluate the association between presence and absence of circulating tumor DNA mutation with the tumor burden assessed by using the radiological findings and pre-treatment fludeoxyglucose (FDG) positron emission tomography (PET)-derived metrics: metabolic tumor volume (MTV), maximum standardized uptake value (SUVmax), total glycolytic activity (TGA).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)
Time Frame: Up to 2 years
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.
Secondary Outcomes
- 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 FDG-PET tumor hypermetabolism status(Up to 2 years)
- Correlation between circulating tumor cells and circulating tumor DNA(Up to 2 years)
- Correlation between mutations found in plasma and tissue mutations(Up to 2 years)
- Association between absence and presence of circulating tumor DNA mutation with the tumor burden(Up to 2 years)