Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- Stage IIIA Non-Small Cell Lung Cancer
- Stage IVB Salivary Gland Cancer
- Stage IVB Verrucous Carcinoma of the Larynx
- Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Salivary Gland Cancer
- Stage IVA Verrucous Carcinoma of the Larynx
- Stage IVC Squamous Cell Carcinoma of the Oropharynx
- Tongue Cancer
- Salivary Gland Squamous Cell Carcinoma
- 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 Verrucous Carcinoma of the Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Larynx
- Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
- Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Larynx
- Stage IVB Verrucous Carcinoma of the Oral Cavity
- Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Squamous Cell Carcinoma of the Larynx
- Stage IVB Squamous Cell Carcinoma of the Oropharynx
- Stage IVC Verrucous Carcinoma of the Larynx
- Stage IVA Squamous Cell Carcinoma of the Oropharynx
- Stage IVC Verrucous Carcinoma of the Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 DN...
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 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.
Tracking Information
- NCT #
- NCT02245100
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Voichita Bar-Ad, MD Thomas Jefferson University