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Development and Validation of a qPCR Cell Free DNA Assay as a Potential Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892096
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cadex Genomics

Brief Summary:
Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).

Condition or disease Intervention/treatment
Metastatic Non-Small Cell Lung Carcinoma Metastatic Colorectal Cancer Metastatic Breast Cancer Diagnostic Test: Blood-based cell-free cfDNA qPCR assay

Detailed Description:

Most anticancer drugs are effective only in subgroups of patients, and our current understanding of tumor biology does not allow us to predict accurately which patient will benefit from a specific therapeutic regimen. The definitive proof of the effectiveness of a therapy is improvement in clinical symptoms and survival. Imaging is generally used to assess therapeutic effects earlier and more objectively. Current response assessment is based primarily on changes in tumor size as measured by CT or other anatomic imaging modalities.

Cadex Genomics has developed an analytically validated cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay that utilizes standard qPCR platforms for processing, this test can reliably obtain results from small blood volumes and possesses exceptionally high analytical sensitivity of circulating cfDNA.

The purpose of this study is to accrue samples for the further development and clinical validation of a blood-based cell-free cfDNA qPCR assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Multiplex qPCR Short Fragment Cell Free DNA Assay as a Potential Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Metastatic Lung Cancer, Colorectal Cancer or Breast Cancer
A total of 750 subjects with lung cancer, CRC and breast cancer will be consecutively enrolled. It is expected that 250 subjects will be lung cancer patients, 250 mCRC patients and 250 breast cancer patients.
Diagnostic Test: Blood-based cell-free cfDNA qPCR assay
Up to 30mL of blood via venipuncture




Primary Outcome Measures :
  1. DNA Integrity Index as a predictor of progressive disease in a cohort of metastatic patients (250 Lung Cancer (NSCLC, SCLC), 250 CRC and 250 BC patients as compared to standard RECIST/iRECIST criteria. [ Time Frame: Six months to accrue patient for initial development ]
    A total of 750 subjects (250 stage IV Lung Cancer, IV 250 CRC and IV BC) will be enrolled consecutively into the study. Blood specimens will be collected at the initiation of therapy and 12 to 16 days after the initiation of therapy. A course of therapy is defined as chemotherapy, immunotherapy or oral therapy. Standard baseline RECIST or iRECIST will be recorded before the initiation therapy and again at 9-12 weeks. For those patients who are receiving single agent regimen consisting of immunotherapy alone there will be an additional blood draw prior to administration of the second course of therapy. The Integrity Index will be evaluated for predicting early non-response to therapy as compared to standard RECIST/iRECIST results.


Biospecimen Retention:   Samples With DNA
Up to 30mL of blood via venipuncture


Information from the National Library of Medicine

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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:   Probability Sample
Study Population
A total of 750 subjects with Lung Cancer, CRC or BC will be enrolled consecutively into each cancer group. It is expected that each group will enroll 250 subjects each. As each group meets its enrollment goals, that group will close to further enrollment.
Criteria

Inclusion Criteria:

Age ≥ 18 years.

Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease):

BC patients who meet the following criteria:

ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (> 1 cm by RECIST) predominantly lytic bone lesions

Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy.

Imaging to determine RECIST and/or iRECIST criteria:

If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw.

If baseline test is performed at the completion of a cycle of therapy, CT or MRI or PET/CT monitoring should be completed to coincide with end of cycle of therapy and prior to baseline blood draw.

Planned CT or MRI or PET/CT monitoring for treatment response completed within 8-12 weeks of start of treatment.

Willing and able to donate up to 30mL of blood at each blood draw. Willing and able to provide informed consent.

Exclusion Criteria:

Diagnosis of a secondary malignancy that is not in complete remission. Imaging to determine RECIST and/or iRECIST criteria is not planned or available.

CT or MRI or PET/CT monitoring for treatment response is not planned within 8-12 weeks.

Presence of active autoimmune disease which is under active treatment. DVT, PE, sepsis, or has recovered from any other serious illness within the prior 2 weeks of the baseline blood draw. (Note: Patients who have recovered from similar conditions more than 2 weeks prior to the baseline blood draw would be eligible for the study) If initiating a new line of therapy, patient has received any doses of the new block of therapy before the first designated blood draw.

If continuing current line of therapy after CT, MRI or PET/CT monitoring, patient has received subsequent cycle of therapy before the first designated blood draw.

Performance status ECOG ≥3. Evidence of acute renal failure as determined by current clinical guidelines. NSCLC, SCLC or CRC patients beyond 9 months of the initiation of therapy, on 1st line immunotherapy alone, or combination immunotherapy and chemotherapy regimens. (Note: patients on subsequent lines of therapy (2nd,3rd line etc.) would be eligible at any time point including prior to the 9 months vs those patients on 1st line therapy)..


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): NCT03892096


Locations
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United States, Arkansas
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Health - Palo Alto Medical Foundation
Sunnyvale, California, United States, 94086
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Georgia
IACT Health
Columbus, Georgia, United States, 31904
United States, Louisiana
University Medical Center
New Orleans, Louisiana, United States, 70112
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States, 70119
United States, Nebraska
Nebraska Cancer Center
Omaha, Nebraska, United States, 68130
United States, New York
National Translational Research Group LLC
Port Jefferson Station, New York, United States, 11776
United States, North Carolina
Waverly Hematology Oncology
Cary, North Carolina, United States, 27518
Advent Health
Hendersonville, North Carolina, United States, 28732
United States, South Carolina
Greenville Health System - Prisma Health
Greenville, South Carolina, United States, 29605
Canada, Quebec
McGill University
Montréal, Quebec, Canada, H3H 2R9
Sponsors and Collaborators
Cadex Genomics
Investigators
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Study Director: Christer Svedman, M.D. Ph.D. Cadex Genomics
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Responsible Party: Cadex Genomics
ClinicalTrials.gov Identifier: NCT03892096    
Other Study ID Numbers: CADEX-0001
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Neoplasms
Neoplastic Processes
Pathologic Processes
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms