MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

NCT05219734 | Active Not Recruiting

• 1 other identifier: CR-001-016
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients. Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.

Conditions

Cancer; Solid Tumor; Non Small Cell Lung Cancer; Colorectal Cancer; Bladder Cancer

Keywords

minimal residual disease; MRD; ctDNA; circulating tumor DNA

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Through study completion, up to 5 years

• Relapse Free Survival

  Measured through study completion, assessed yearly up to 3 years

Interventions

Personalized Cancer Monitoring (PCM) DIAGNOSTIC_TEST

personalized molecular test for solid tumor cancer patients that may detect the presence of circulating tumor DNA (ctDNA) and molecular residual disease (MRD), also known as minimal residual disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study seeks to enroll patients of all solid tumor types across many clinical sites with emphasis on early stage non-metastatic Colorectal, Non small cell lung cancer, breast, ovarian and bladder cancers.

You may qualify if:

• Stated ability to give informed consent by participant.
• Stated health status of participant as healthy enough to provide Biological Material.
• Individuals diagnosed with solid cancer of any type, including but not limited to colorectal, non-small cell lung, breast, ovarian and bladder cancers, regardless of the length of time since diagnosis and regardless of previous therapies.
• Participant is of any biological sex and \>18 years of age
• Participant has not undergone a blood transfusion within the previous three weeks

You may not qualify if:

• Participants who are deemed medically unstable
• Participants who are deemed to be "difficult to draw" blood from.
• Participants who are \<18 years of age
• Participants diagnosed with CNS cancers, sarcomas or hematologic malignancies such as leukemia or lymphoma .
• Participants with more than one primary cancer
• Participants with FFPE slides older than 10 years
• Participants who are pregnant
• Any other reason that, in the Investigator's judgment, that would preclude the participant from being able to participate in the study
• Participants for which a pathology report is not available

Sponsors & Collaborators

• Invitae Corporation: lead

Study Sites (2)

Columbus Regional Health

Columbus, Indiana, 47201, United States

Location

Onslow Radiation

Jacksonville, North Carolina, 28546, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples type to be collected is blood.

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Urinary Bladder Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ed Esplin, MD, PhD

  Invitae Corporation

  STUDY DIRECTOR

• Michael Korn

  Invitae Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 2, 2022
• Study Start: November 29, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)