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

NCT03892096 | Completed

• 1 other identifier: CADEX-0001
• Study Type: observational
• Target: 130
• Locations: 2 countries
• Sites: 12

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).

Conditions

Metastatic Non-Small Cell Lung Carcinoma; Metastatic Colorectal Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  Six months to accrue patient for initial development

Study Arms (1)

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

Interventions

Blood-based cell-free cfDNA qPCR assay DIAGNOSTIC_TEST

Up to 30mL of blood via venipuncture

Metastatic Lung Cancer, Colorectal Cancer or Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)..

Sponsors & Collaborators

• Cadex Genomics: lead

Study Sites (12)

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

Location

Sutter Health - Palo Alto Medical Foundation

Sunnyvale, California, 94086, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

IACT Health

Columbus, Georgia, 31904, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70119, United States

Location

Nebraska Cancer Center

Omaha, Nebraska, 68130, United States

Location

National Translational Research Group LLC

Port Jefferson Station, New York, 11776, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Advent Health

Hendersonville, North Carolina, 28732, United States

Location

Greenville Health System - Prisma Health

Greenville, South Carolina, 29605, United States

Location

McGill University

Montreal, Quebec, H3H 2R9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Up to 30mL of blood via venipuncture

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christer Svedman, M.D. Ph.D.

  Cadex Genomics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: March 1, 2019
• Primary Completion: November 15, 2023
• Study Completion: February 6, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (11)