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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: 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

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 Summary:

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).

IV. To quantify tumor-specific exosomes from plasma. V. To evaluate the utility of cancer-derived exosomes to serve as prognostic biomarkers for real-time monitoring of therapeutic efficacy and identifying early recurrence using longitudinal samples from cancer patients undergoing treatment.

OUTLINE:

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 sa
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation between plasma tumor DNA levels and salivary tumor DNA levels [ Time Frame: Up to 2 years ]
    The correlation between plasma tumor DNA and salivary tumor DNA levels will be modeled through linear regression with least squares approach or using the Spearman correlation coefficient.
  • Association between absence and presence of circulating tumor DNA mutation with the tumor burden [ Time Frame: Up to 2 years ]
    Univariate chi-square tests will be used to access the association between absence and presence of circulating tumor DNA mutation with the tumor burden.
  • Association between absence and presence of circulating tumor DNA mutation with FDG-PET tumor hypermetabolism status [ Time Frame: Up to 2 years ]
    Univariate chi-square tests will be used to access the association between absence and presence of circulating tumor DNA mutation with FDG-PET tumor hypermetabolism status.
  • Correlation between mutations found in plasma and tissue mutations [ Time Frame: Up to 2 years ]
    The correlation between mutations found in plasma and tissue mutations will be first explored by univariate chi-square test and then multivariable logistic regression.


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: August 21, 2014
Date Started: July 2014
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016