Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Inclusion Criteria

ECOG performance status score of 0-3
Patients older than 18 years age
Life expectancy of 3 months or longer
...
ECOG performance status score of 0-3
Patients older than 18 years age
Life expectancy of 3 months or longer
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)
Patients able to provide a written informed consent prior to study entry

Exclusion Criteria

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
Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
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
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
Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
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

Summary

Conditions
  • Stage IIIA Non-Small Cell Lung Cancer
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IIIB Non Small Cell Lung Cancer
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Non-small Cell Lung Cancer
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Tongue Cancer
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Salivary Gland Cancer
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Salivary Gland Cancer
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary
  • Stage IVB Salivary Gland Cancer
Type
Observational
Design
  • Observational Model: Case-Only
  • Time 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.

Inclusion Criteria

ECOG performance status score of 0-3
Patients older than 18 years age
Life expectancy of 3 months or longer
...
ECOG performance status score of 0-3
Patients older than 18 years age
Life expectancy of 3 months or longer
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)
Patients able to provide a written informed consent prior to study entry

Exclusion Criteria

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
Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
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
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
Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
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

Locations

Philadelphia, Pennsylvania, 19107
Philadelphia, Pennsylvania, 19107

Tracking Information

NCT #
NCT02245100
Collaborators
Not Provided
Investigators
  • Principal Investigator: Voichita Bar-Ad, MD Thomas Jefferson University
  • Voichita Bar-Ad, MD Thomas Jefferson University