Colo-rectal CancerNCT06654622
Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer
An observational study of Colo-rectal Cancer and Colorectal Cancer Recurrent, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Colorectal Cancer Recurrent
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 18 Feb 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients with stage II-III colorectal cancer who have undergone curative surgery and require assessment for molecular residual disease to determine whether adjuvant chemotherapy is necessary.
Who may be able to join
- Patients with pathologically confirmed stage II or III colorectal cancer.
- Patients who have undergone curative-intent surgery.
- Patients with no evidence of distant metastasis (stage IV).
- Patients aged 18 years or older.
- Patients who provided written informed consent.
Who cannot join
- Patients with stage IV cancer or those receiving neoadjuvant therapy.
- Patients with non-curative resection or requiring urgent surgery.
- Patients with a follow-up period of fewer than 3 years.
- Patients with severe comorbidities or who are unable to participate in follow-up assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.
Read the detailed description
The current standard for treating stage II-III colorectal cancer involves surgical resection, often followed by adjuvant chemotherapy (ACT) for high-risk patients. However, identifying patients who would benefit most from ACT remains challenging. Molecular residual disease (MRD) in these patients is a critical factor in determining the likelihood of recurrence. This study aims to develop an exosome-based liquid biopsy assay using circulating exosomal microRNAs (exo-miRNAs) to predict the presence of MRD in postoperative patients. By analyzing exo-miRNAs from blood samples collected after surgery, the goal is to identify high-risk patients who may benefit from ACT while sparing low-risk patients from unnecessary treatment. A risk-stratification model, termed the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction (EMRATI) score, will be developed to improve ACT decision-making and enhance clinical outcomes for stage II-III CRC patients.
- Conditions
- Colo-rectal Cancer, Colorectal Cancer Recurrent
- Keywords
- Colorectal cancer, Molecular residual disease, Adjuvant chemotherapy, Stage II-III CRC, exosomal miRNA
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort (Recurrence Group) | Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel). | |
| Training Cohort (Non-Recurrence Group) | Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel). | |
| Testing Cohort (Recurrence Group) | Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence. | |
| Testing Cohort (Non-Recurrence Group) | Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Evaluation (Recurrence)
Assessment of tumor recurrence through clinical and imaging evaluations.
Measured: Follow-up at regular intervals during the first 3 years post-surgery.
Secondary outcomes (1)
Overall Survival (OS)
Evaluation of the overall survival (OS) of patients, defined as the time from surgery to death from any cause.
Measured: Patients will be monitored for overall survival for up to 5 years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Apr 2023
- Primary completion18 Jan 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654622
- Sponsor's protocol ID
- 23228/CRMRD
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou H, Zhu L, Song J, Wang G, Li P, Li W, Luo P, Sun X, Wu J, Liu Y, Zhu S, Zhang Y. Liquid biopsy at the frontier of detection, prognosis and progression monitoring in colorectal cancer. Mol Cancer. 2022 Mar 25;21(1):86. doi: 10.1186/s12943-022-01556-2.
PubMed 35337361Ruiz-Banobre J, Roy R, Alustiza Fernandez M, Murcia O, Jover R, Pera M, Balaguer F, Lopez-Lopez R, Goel A. Clinical significance of a microRNA signature for the identification and predicting prognosis in colorectal cancers with mucinous differentiation. Carcinogenesis. 2020 Nov 13;41(11):1498-1506. doi: 10.1093/carcin/bgaa097.
PubMed 32911537Matsuyama T, Toiyama Y, Ishikawa T, Okugawa Y, Yasuno M, Maurel J, Kinugasa Y, Uetake H, Goel A. A metastasis-associated microRNA-based liquid biopsy signature for risk-stratification in colorectal cancer: a multicenter cohort study. Clin Transl Med. 2022 Dec;12(12):e998. doi: 10.1002/ctm2.998. No abstract available.
PubMed 36513881Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.
PubMed 36609320Mo S, Ye L, Wang D, Han L, Zhou S, Wang H, Dai W, Wang Y, Luo W, Wang R, Xu Y, Cai S, Liu R, Wang Z, Cai G. Early Detection of Molecular Residual Disease and Risk Stratification for Stage I to III Colorectal Cancer via Circulating Tumor DNA Methylation. JAMA Oncol. 2023 Jun 1;9(6):770-778. doi: 10.1001/jamaoncol.2023.0425.
PubMed 37079312Yoshino T, Argiles G, Oki E, Martinelli E, Taniguchi H, Arnold D, Mishima S, Li Y, Smruti BK, Ahn JB, Faud I, Chee CE, Yeh KH, Lin PC, Chua C, Hasbullah HH, Lee MA, Sharma A, Sun Y, Curigliano G, Bando H, Lordick F, Yamanaka T, Tabernero J, Baba E, Cervantes A, Ohtsu A, Peters S, Ishioka C, Pentheroudakis G. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis treatment and follow-up of patients with localised colon cancer. Ann Oncol. 2021 Dec;32(12):1496-1510. doi: 10.1016/j.annonc.2021.08.1752. Epub 2021 Aug 16.
PubMed 34411693Montcusi B, Madrid-Gambin F, Marin S, Mayol X, Pascual M, Cascante M, Pozo OJ, Pera M. Circulating Metabolic Markers Identify Patients at Risk for Tumor Recurrence: A Prospective Cohort Study in Colorectal Cancer Surgery. Ann Surg. 2024 Nov 1;280(5):842-849. doi: 10.1097/SLA.0000000000006463. Epub 2024 Aug 1.
PubMed 39087328Kotani D, Oki E, Nakamura Y, Yukami H, Mishima S, Bando H, Shirasu H, Yamazaki K, Watanabe J, Kotaka M, Hirata K, Akazawa N, Kataoka K, Sharma S, Aushev VN, Aleshin A, Misumi T, Taniguchi H, Takemasa I, Kato T, Mori M, Yoshino T. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nat Med. 2023 Jan;29(1):127-134. doi: 10.1038/s41591-022-02115-4. Epub 2023 Jan 16.
PubMed 36646802Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.
PubMed 35657320Kandimalla R, Gao F, Matsuyama T, Ishikawa T, Uetake H, Takahashi N, Yamada Y, Becerra C, Kopetz S, Wang X, Goel A. Genome-wide Discovery and Identification of a Novel miRNA Signature for Recurrence Prediction in Stage II and III Colorectal Cancer. Clin Cancer Res. 2018 Aug 15;24(16):3867-3877. doi: 10.1158/1078-0432.CCR-17-3236. Epub 2018 Mar 7.
PubMed 29514841Miyazaki K, Montcusi B, Morine Y, Okuno K, Pascual M, Tokunaga T, Noma T, Kinugasa Y, Shimada M, Cai G, Pera M, Goel A. An exosome-based liquid biopsy to predict molecular residual disease for the identification of high-risk patients with stage II-III colorectal cancer: the CLEAR study. Mol Cancer. 2026 Mar 3;25(1):136. doi: 10.1186/s12943-026-02624-7.
PubMed 41776599
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06654622
- Acronym / sponsor ID
- 23228/CRMRD
- Conditions
- Colo-rectal Cancer, Colorectal Cancer Recurrent
- Keywords
- Colorectal cancer, Molecular residual disease, Adjuvant chemotherapy, Stage II-III CRC, exosomal miRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.
Detailed description
The current standard for treating stage II-III colorectal cancer involves surgical resection, often followed by adjuvant chemotherapy (ACT) for high-risk patients. However, identifying patients who would benefit most from ACT remains challenging. Molecular residual disease (MRD) in these patients is a critical factor in determining the likelihood of recurrence. This study aims to develop an exosome-based liquid biopsy assay using circulating exosomal microRNAs (exo-miRNAs) to predict the presence of MRD in postoperative patients. By analyzing exo-miRNAs from blood samples collected after surgery, the goal is to identify high-risk patients who may benefit from ACT while sparing low-risk patients from unnecessary treatment. A risk-stratification model, termed the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction (EMRATI) score, will be developed to improve ACT decision-making and enhance clinical outcomes for stage II-III CRC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training Cohort (Recurrence Group) | – | –Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel). |
| Training Cohort (Non-Recurrence Group) | – | –Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel). |
| Testing Cohort (Recurrence Group) | – | –Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence. |
| Testing Cohort (Non-Recurrence Group) | – | –Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients with stage II-III colorectal cancer who have undergone curative surgery and require assessment for molecular residual disease to determine whether adjuvant chemotherapy is necessary.
Key inclusion criteria (5 listed)
- Patients with pathologically confirmed stage II or III colorectal cancer.
- Patients who have undergone curative-intent surgery.
- Patients with no evidence of distant metastasis (stage IV).
- Patients aged 18 years or older.
- Patients who provided written informed consent.
Key exclusion criteria (4 listed)
- Patients with stage IV cancer or those receiving neoadjuvant therapy.
- Patients with non-curative resection or requiring urgent surgery.
- Patients with a follow-up period of fewer than 3 years.
- Patients with severe comorbidities or who are unable to participate in follow-up assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor Evaluation (Recurrence)
Time frame: Follow-up at regular intervals during the first 3 years post-surgery.
Assessment of tumor recurrence through clinical and imaging evaluations.
1 secondary outcome
Overall Survival (OS)
Time frame: Patients will be monitored for overall survival for up to 5 years post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 35337361Zhou H, Zhu L, Song J, Wang G, Li P, Li W, Luo P, Sun X, Wu J, Liu Y, Zhu S, Zhang Y. Liquid biopsy at the frontier of detection, prognosis and progression monitoring in colorectal cancer. Mol Cancer. 2022 Mar 25;21(1):86. doi: 10.1186/s12943-022-01556-2.
- Background: PubMed 32911537Ruiz-Banobre J, Roy R, Alustiza Fernandez M, Murcia O, Jover R, Pera M, Balaguer F, Lopez-Lopez R, Goel A. Clinical significance of a microRNA signature for the identification and predicting prognosis in colorectal cancers with mucinous differentiation. Carcinogenesis. 2020 Nov 13;41(11):1498-1506. doi: 10.1093/carcin/bgaa097.
- Background: PubMed 36513881Matsuyama T, Toiyama Y, Ishikawa T, Okugawa Y, Yasuno M, Maurel J, Kinugasa Y, Uetake H, Goel A. A metastasis-associated microRNA-based liquid biopsy signature for risk-stratification in colorectal cancer: a multicenter cohort study. Clin Transl Med. 2022 Dec;12(12):e998. doi: 10.1002/ctm2.998. No abstract available.
- Background: PubMed 36609320Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.
- Background: PubMed 37079312Mo S, Ye L, Wang D, Han L, Zhou S, Wang H, Dai W, Wang Y, Luo W, Wang R, Xu Y, Cai S, Liu R, Wang Z, Cai G. Early Detection of Molecular Residual Disease and Risk Stratification for Stage I to III Colorectal Cancer via Circulating Tumor DNA Methylation. JAMA Oncol. 2023 Jun 1;9(6):770-778. doi: 10.1001/jamaoncol.2023.0425.
- Background: PubMed 34411693Yoshino T, Argiles G, Oki E, Martinelli E, Taniguchi H, Arnold D, Mishima S, Li Y, Smruti BK, Ahn JB, Faud I, Chee CE, Yeh KH, Lin PC, Chua C, Hasbullah HH, Lee MA, Sharma A, Sun Y, Curigliano G, Bando H, Lordick F, Yamanaka T, Tabernero J, Baba E, Cervantes A, Ohtsu A, Peters S, Ishioka C, Pentheroudakis G. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis treatment and follow-up of patients with localised colon cancer. Ann Oncol. 2021 Dec;32(12):1496-1510. doi: 10.1016/j.annonc.2021.08.1752. Epub 2021 Aug 16.
- Background: PubMed 39087328Montcusi B, Madrid-Gambin F, Marin S, Mayol X, Pascual M, Cascante M, Pozo OJ, Pera M. Circulating Metabolic Markers Identify Patients at Risk for Tumor Recurrence: A Prospective Cohort Study in Colorectal Cancer Surgery. Ann Surg. 2024 Nov 1;280(5):842-849. doi: 10.1097/SLA.0000000000006463. Epub 2024 Aug 1.
- Background: PubMed 36646802Kotani D, Oki E, Nakamura Y, Yukami H, Mishima S, Bando H, Shirasu H, Yamazaki K, Watanabe J, Kotaka M, Hirata K, Akazawa N, Kataoka K, Sharma S, Aushev VN, Aleshin A, Misumi T, Taniguchi H, Takemasa I, Kato T, Mori M, Yoshino T. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nat Med. 2023 Jan;29(1):127-134. doi: 10.1038/s41591-022-02115-4. Epub 2023 Jan 16.
- Background: PubMed 35657320Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.
- Background: PubMed 29514841Kandimalla R, Gao F, Matsuyama T, Ishikawa T, Uetake H, Takahashi N, Yamada Y, Becerra C, Kopetz S, Wang X, Goel A. Genome-wide Discovery and Identification of a Novel miRNA Signature for Recurrence Prediction in Stage II and III Colorectal Cancer. Clin Cancer Res. 2018 Aug 15;24(16):3867-3877. doi: 10.1158/1078-0432.CCR-17-3236. Epub 2018 Mar 7.
- Derived from this study: PubMed 41776599Miyazaki K, Montcusi B, Morine Y, Okuno K, Pascual M, Tokunaga T, Noma T, Kinugasa Y, Shimada M, Cai G, Pera M, Goel A. An exosome-based liquid biopsy to predict molecular residual disease for the identification of high-risk patients with stage II-III colorectal cancer: the CLEAR study. Mol Cancer. 2026 Mar 3;25(1):136. doi: 10.1186/s12943-026-02624-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Colorectal Cancer Recurrent, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Evaluation (Recurrence) (time frame: Follow-up at regular intervals during the first 3 years post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654622, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.