MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pan-tumor MRD Study

NCT06605404

Muscle Invasive Bladder Urothelial Carcinoma Esophageal Cancer Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma +4 more

RECRUITING

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

NCT02838836

Non-small Cell Lung Cancer Esophageal Cancer Gastric Cancer +3 more

RECRUITING

Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

NCT03551951

Non Small Cell Lung Cancer Esophageal Cancer Gastric Cancer +3 more

RECRUITING

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance

NCT00026663

Renal Cell Carcinoma Lung Carcinoma Cervical Carcinoma

COMPLETED

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Ann Arbor Stage I Lymphoma +59 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study involves collection of tumor tissue (from a standard biopsy and/or surgery) as well as blood samples over time in order to allow the creation of a Personalized Cancer Monitoring (PCM) assay. Additional blood samples are taken throughout the patient's treatment and follow-up period.

Each participant will submit one blood sample when they begin participation in the research study. Participants will be asked to submit follow up samples several times per year (annually, at minimum), with the exact frequency varying by stage and type of cancer. In general, participants will not be asked to come into the clinic more frequently than their already needed clinic visits.

If the cancer-specific mutations identified by the PCM are detected in the blood samples provided as part of the study, this may would suggests that residual cancer may be present. This is an observational study comparing MRD results to standard of care methods and collecting provider and patient perspectives, using surveys. Physicians will be informed of all PCM results in the form of a clinical report. Physicians are not asked to base treatment decisions on these results.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Personalized Cancer Monitoring (PCM)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Stated ability to give informed consent by participant.
2. Stated health status of participant as healthy enough to provide Biological Material.
3. 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.
4. Participant is of any biological sex and \>18 years of age
5. Participant has not undergone a blood transfusion within the previous three weeks

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No