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

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ClinicalTrials.gov Identifier: NCT02245100
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment
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 Other: Cytology specimen Other: Laboratory biomarker analysis

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).

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 22, 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020


Group/Cohort Intervention/treatment
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
Correlative studies
Other Name: Cytologic sampling

Other: Laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Blood, saliva, and tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with advanced head and neck carcinoma or NSCLC enrolled at Thomas Jefferson University
Criteria

Inclusion Criteria:

  1. Patients older than 18 years age
  2. 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)
  3. ECOG performance status score of 0-3
  4. Life expectancy of 3 months or longer
  5. Patients able to provide a written informed consent prior to study entry

Exclusion Criteria:

  1. Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
  2. 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
  3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245100


Contacts
Contact: Voichita Bar-Ad, MD 215-955-8619
Contact: Radiation Oncology Protocol Office 215-955-8619

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Voichita Bar-Ad, MD    215-955-8619      
Contact: Radiation Oncology Protocol Office    215-955-8619      
Principal Investigator: Voichita Bar-Ad, MD         
Sub-Investigator: Robert Den, MD         
Sub-Investigator: Adam Dicker, MD, PhD         
Sub-Investigator: Maria Werner-Wasik, MD         
Sub-Investigator: Wenyin Shi, MD, PhD         
Sub-Investigator: Pramila R Anne, MD         
Sub-Investigator: Nicole Simone, MD         
Sub-Investigator: Mark Hurwitz, MD         
Sub-Investigator: Rita Axelrod, MD         
Sub-Investigator: David Cognetti, MD         
Sub-Investigator: Bo Lu, MD         
Sub-Investigator: Joseph Curry, MD         
Sub-Investigator: Scott Cowan, MD         
Sub-Investigator: Nathaniel Evans, MD         
Sub-Investigator: Adam Luginbuhl, MD         
Sub-Investigator: Jennifer Johnson, MD, PhD         
Sub-Investigator: Ulrich Rodeck, MD         
Sub-Investigator: Hushan Yang, PhD         
Sub-Investigator: Ubaldo Martinez-Outschoorn, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Voichita Bar-Ad, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02245100     History of Changes
Other Study ID Numbers: 14D.172
2014-010 ( Other Identifier: CCRRC )
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Salivary Gland Diseases
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Diseases
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Nasopharyngeal Neoplasms
Paranasal Sinus Neoplasms
Neoplasms, Unknown Primary
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases