Health TrialsbyHealthPanel

Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study

ConditionsColorectal AdenocarcinomaStage I Colorectal Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v6Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Histological/cytological confirmation of colorectal adenocarcinoma.

Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.

Ability to understand and the willingness to sign a written informed consent document.

Disqualifiers

Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and / or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial population

Patients with colorectal cancer at MD Anderson Cancer Center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and tissue samples

  • Electronic Health Record Review

    Other intervention

    Review of medical records

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (biospecimen collection)2 interventions

Trial outcomes

Primary outcomes

1

Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma

To detect circulating tumor DNA (ctDNA) in plasma samples from patients with colorectal cancer (CRC) who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.

Time frame
Up to 5 years
2

Detection of recurrences post completion of curative therapies

To detect ctDNA in plasma samples from patients with CRC who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.

Time frame
Up to 5 years

Secondary outcomes

1

Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance

Will assess the association between changes in circulating molecules and response in patients undergoing neoadjuvant therapy by linear or logistic regression models

Time frame
Baseline up to 5 years
2

Disease free survival (DFS)

Time frame
Up to 5 years
3

Overall survival (OS)

Time frame
Up to 5 years

Other outcomes

1

Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences

Time frame
Up to 5 years
2

Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences

Time frame
Up to 5 years
3

Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS

Time frame
Up to 5 years
4

Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations

Time frame
Up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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