Colon CancerEXPOSENCT07255729
An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer
An observational study of Colon Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） and Diagnostic Test: EXPOSE RT-qPCR panel
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 18 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.
Who may be able to join
- Pathologically confirmed colon cancer (Stage I-IV, UICC TNM 8th edition)
- Underwent curative-intent resection (with or without perioperative therapy)
- Preoperative plasma (or serum) samples available
- Clinical and prognostic data available
Who cannot join
- No written informed consent
- Missing preoperative blood samples
- Missing survival/recurrence data
- Duplicate cases
- Non-adenocarcinoma histology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91016
Ajay Goel, PhD, 626-218-3452, ajgoel@coh.org
About this study
Official title: Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.
Read the detailed description
Colon cancer remains one of the leading causes of cancer-related mortality worldwide, and despite advances in screening and surgical techniques, a substantial proportion of patients continue to experience disease recurrence after curative resection. For patients with pathological stage IIB or higher disease, adjuvant chemotherapy is routinely recommended due to their elevated recurrence risk. However, accurately identifying these biologically aggressive cases before surgery remains a major clinical challenge, as current imaging-based staging often underestimates tumor burden and fails to capture underlying malignant potential. This diagnostic gap has hindered the optimal implementation of neoadjuvant chemotherapy (NAC) in colon cancer.
To address this issue, the investigators established the EXPOSE study (Exosomal microRNA Signature for Pre-Operative Stage and Eligibility Evaluation), a multicenter translational research initiative aiming to develop and validate a noninvasive, biologically informed diagnostic assay capable of identifying patients with high-risk colon cancer-equivalent to pathological stage IIB or higher-who may benefit from NAC.
The EXPOSE study will proceed through three structured phases.
- In the discovery phase, exosomal microRNAs will be profiled using comprehensive small RNA sequencing to identify key biomarkers reflecting tumor aggressiveness.
- In the training phase, the investigators will quantify candidate microRNAs using RT-qPCR and integrate their expression patterns via machine-learning algorithms to construct a predictive model for high-risk disease.
- Finally, in the validation phase, the model's reproducibility, diagnostic accuracy, and generalizability will be tested in an independent clinical cohort.
The final EXPOSE assay is expected to serve as a liquid biopsy-based tool for preoperative staging, enabling more precise identification of biologically advanced colon cancer cases. Upon completion, this study will deliver a rigorously validated diagnostic model that combines molecular and clinical data to guide neoadjuvant treatment decisions and enhance personalized care in colon cancer management.
- Conditions
- Colon Cancer
- Being tested
- Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）, Diagnostic Test: EXPOSE RT-qPCR panel
- Keywords
- CC, NAC, miRNA, Exosomal miRNA, Staging, liquid biopsy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）Diagnostic test
Candidates identified from small RNA sequencing
Diagnostic Test: EXPOSE RT-qPCR panelDiagnostic test
Quantification of exosomal microRNAs (RT-qPCR)
| Study group | Role | What they receive |
|---|---|---|
| High-risk Colon Cancer (Discovery) | Stage IIB-IV colon cancer; used to identify biomarker candidates Receives: Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） | |
| Low-risk Colon Cancer (Discovery) | Stage I-IIA colon cancer Receives: Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） | |
| High-risk Colon Cancer (Training) | Pathological Stage IIB-IV; used to build model Receives: Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel | |
| Low-risk Colon Cancer (Training) | Pathological Stage I-IIA Receives: Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel | |
| High-risk Colon Cancer (Validation) | Stage IIB-IV in independent cohort Receives: Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel | |
| Low-risk Colon Cancer (Validation) | Stage I-IIA in independent cohort Receives: Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Stage IIB or higher patients
Measured: At time of pathology (1year after surgery)
Secondary outcomes (2)
Recurrence-Free Survival (RFS)
Measured: Up to 120 months
Overall survival (OS)
Measured: Up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start15 Jan 2025
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- Retrospective
- Enrolment
- 400 participants (estimated)
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
- NCT07255729
- Sponsor's protocol ID
- 23228/EXPOSE
- Acronym
- EXPOSE
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Publications
Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8.
PubMed 36604116Cardoso R, Guo F, Heisser T, Hackl M, Ihle P, De Schutter H, Van Damme N, Valerianova Z, Atanasov T, Majek O, Muzik J, Nilbert MC, Tybjerg AJ, Innos K, Magi M, Malila N, Bouvier AM, Bouvier V, Launoy G, Woronoff AS, Cariou M, Robaszkiewicz M, Delafosse P, Poncet F, Katalinic A, Walsh PM, Senore C, Rosso S, Vincerzevskiene I, Lemmens VEPP, Elferink MAG, Johannesen TB, Korner H, Pfeffer F, Bento MJ, Rodrigues J, Alves da Costa F, Miranda A, Zadnik V, Zagar T, Lopez de Munain Marques A, Marcos-Gragera R, Puigdemont M, Galceran J, Carulla M, Chirlaque MD, Ballesta M, Sundquist K, Sundquist J, Weber M, Jordan A, Herrmann C, Mousavi M, Ryzhov A, Hoffmeister M, Brenner H. Colorectal cancer incidence, mortality, and stage distribution in European countries in the colorectal cancer screening era: an international population-based study. Lancet Oncol. 2021 Jul;22(7):1002-1013. doi: 10.1016/S1470-2045(21)00199-6. Epub 2021 May 25.
PubMed 34048685Taieb J, Svrcek M, Cohen R, Basile D, Tougeron D, Phelip JM. Deficient mismatch repair/microsatellite unstable colorectal cancer: Diagnosis, prognosis and treatment. Eur J Cancer. 2022 Nov;175:136-157. doi: 10.1016/j.ejca.2022.07.020. Epub 2022 Sep 14.
PubMed 36115290Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
PubMed 38230766Burley N, Lee Y, Liu L, Gangi A, Nasseri Y, Atkins K, Zaghiyan K, Murrell Z, Osipov A, Hendifar A, Hitchins M, Gong J. ctDNA-guided adjuvant immunotherapy in colorectal cancer. Immunotherapy. 2024;16(20-22):1197-1202. doi: 10.1080/1750743X.2024.2430941. Epub 2024 Nov 17.
PubMed 39552190Tan PB, Verschoor YL, van den Berg JG, Balduzzi S, Kok NFM, Ijsselsteijn ME, Moore K, Jurdi A, Tin A, Kaptein P, van Leerdam ME, Haanen JBAG, Voest EE, de Miranda NFCC, Schumacher TN, Wessels LFA, Chalabi M. Neoadjuvant immunotherapy in mismatch-repair-proficient colon cancers. Nature. 2025 Dec;648(8094):726-735. doi: 10.1038/s41586-025-09679-4. Epub 2025 Oct 20.
PubMed 41115454Krsul D, Prenc E, Pozgaj L, Stefok D, Pongrac P, Podolski M, Radicevic AP, Karlovic D, Jerkovic A, Golcic M, Drazic I, Glavas Krsul S, Fuckar Cupic D, Erakovic Haber V, Zelic M. Diagnostic Relevance of miR-185, miR-141, and miR-21 in Colon Carcinoma: Insights into Tumor Sidedness and Reference Gene Selection. Biomedicines. 2025 Oct 10;13(10):2460. doi: 10.3390/biomedicines13102460.
PubMed 41153743Serafin M, Maka M, Szostek J, Kania I, Jablonska B, Mrowiec S. Side-Specific Prognostic Factors in Colon Cancer: A Retrospective Analysis of Right- and Left-Sided Tumors. Cancers (Basel). 2025 Oct 14;17(20):3315. doi: 10.3390/cancers17203315.
PubMed 41154372Miranda J, Torri GB, Andreia Maria da Silva M, Monjardim G, Mariussi M, Schmitt LG, Wiethan CP, Ghezzi TL, Ghezzi CLA, Altmayer S, Dias AB, Horvat N. CT diagnostic performance for preoperative staging of colon cancer: a systematic review and meta-analysis. Eur Radiol. 2026 Feb;36(2):1506-1516. doi: 10.1007/s00330-025-11850-4. Epub 2025 Aug 6.
PubMed 40767870Platt JR, Elliott F, Handley K, Magill L, Quirke P, Seymour MT, West NP, Morton D, Seligmann J, Tolan DJM. CT staging performance in an international trial of neoadjuvant chemotherapy for locally advanced colon cancer. Br J Radiol. 2025 Dec 1;98(1176):2175-2183. doi: 10.1093/bjr/tqaf217.
PubMed 40848246Gosavi R, Heriot A, Narasimhan V, Warrier SK. Perspectives of the Use of Neoadjuvant Therapy in the Management of Locally Advanced and Locally Recurrent Colon Cancer: A Bi-National Survey of Colorectal Surgeons. Asia Pac J Clin Oncol. 2025 Oct 13. doi: 10.1111/ajco.70035. Online ahead of print.
PubMed 41084117Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
PubMed 36657089Patel RD, Patel B, Crnogorac-Jurcevic T. Extracellular Vesicle-Derived miRNAs as Diagnostic Biomarkers for Pancreatic Ductal Adenocarcinoma: A Systematic Review of Methodological Rigour and Clinical Applicability. Biomark Insights. 2025 Oct 25;20:11772719251381960. doi: 10.1177/11772719251381960. eCollection 2025.
PubMed 41180592Xia Y, Li B, Huang Z, Li X, Liu X, Zeng S, Fan Y, Yin J. Entropy-Driven Nucleic Acid Amplifier Based on Spatial Confinement as a "Booster" for Detection of Extracellular Vesicle MicroRNAs to Diagnose Gastric Cancer and Monitor Therapeutic Response. Anal Chem. 2025 Nov 25;97(46):25782-25796. doi: 10.1021/acs.analchem.5c05375. Epub 2025 Nov 3.
PubMed 41182092Yaghobinejad M, Naji M, Alizadeh AM, Aryanezhad S, Khalighfard S, Asadollahi P, Takzare N, Rastegar T. Identification and validation of stage-specific microRNAs and target genes for prostate cancer: Utilizing bioinformatics tools for diagnostic marker discovery. PLoS One. 2025 Nov 4;20(11):e0315366. doi: 10.1371/journal.pone.0315366. eCollection 2025.
PubMed 41187218
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
- ClinicalTrials.gov ID
- NCT07255729
- Acronym / sponsor ID
- EXPOSE / 23228/EXPOSE
- Conditions
- Colon Cancer
- Keywords
- CC, NAC, miRNA, Exosomal miRNA, Staging, liquid biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 1 Dec 2025 (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.
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.
Detailed description
Colon cancer remains one of the leading causes of cancer-related mortality worldwide, and despite advances in screening and surgical techniques, a substantial proportion of patients continue to experience disease recurrence after curative resection. For patients with pathological stage IIB or higher disease, adjuvant chemotherapy is routinely recommended due to their elevated recurrence risk. However, accurately identifying these biologically aggressive cases before surgery remains a major clinical challenge, as current imaging-based staging often underestimates tumor burden and fails to capture underlying malignant potential. This diagnostic gap has hindered the optimal implementation of neoadjuvant chemotherapy (NAC) in colon cancer.
To address this issue, the investigators established the EXPOSE study (Exosomal microRNA Signature for Pre-Operative Stage and Eligibility Evaluation), a multicenter translational research initiative aiming to develop and validate a noninvasive, biologically informed diagnostic assay capable of identifying patients with high-risk colon cancer-equivalent to pathological stage IIB or higher-who may benefit from NAC.
The EXPOSE study will proceed through three structured phases.
- In the discovery phase, exosomal microRNAs will be profiled using comprehensive small RNA sequencing to identify key biomarkers reflecting tumor aggressiveness.
- In the training phase, the investigators will quantify candidate microRNAs using RT-qPCR and integrate their expression patterns via machine-learning algorithms to construct a predictive model for high-risk disease.
- Finally, in the validation phase, the model's reproducibility, diagnostic accuracy, and generalizability will be tested in an independent clinical cohort.
The final EXPOSE assay is expected to serve as a liquid biopsy-based tool for preoperative staging, enabling more precise identification of biologically advanced colon cancer cases. Upon completion, this study will deliver a rigorously validated diagnostic model that combines molecular and clinical data to guide neoadjuvant treatment decisions and enhance personalized care in colon cancer management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High-risk Colon Cancer (Discovery) | – | Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）Stage IIB-IV colon cancer; used to identify biomarker candidates |
| Low-risk Colon Cancer (Discovery) | – | Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）Stage I-IIA colon cancer |
| High-risk Colon Cancer (Training) | – | Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panelPathological Stage IIB-IV; used to build model |
| Low-risk Colon Cancer (Training) | – | Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panelPathological Stage I-IIA |
| High-risk Colon Cancer (Validation) | – | Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panelStage IIB-IV in independent cohort |
| Low-risk Colon Cancer (Validation) | – | Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panelStage I-IIA in independent cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer patients (Stage I-IV) from multiple institutions with preoperative serum or plasma samples and complete pathological staging.
Key inclusion criteria (4 listed)
- Pathologically confirmed colon cancer (Stage I-IV, UICC TNM 8th edition)
- Underwent curative-intent resection (with or without perioperative therapy)
- Preoperative plasma (or serum) samples available
- Clinical and prognostic data available
Key exclusion criteria (5 listed)
- No written informed consent
- Missing preoperative blood samples
- Missing survival/recurrence data
- Duplicate cases
- Non-adenocarcinoma histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）Candidates identified from small RNA sequencing | Diagnostic test | High-risk Colon Cancer (Discovery), Low-risk Colon Cancer (Discovery) |
| Diagnostic Test: EXPOSE RT-qPCR panelQuantification of exosomal microRNAs (RT-qPCR) | Diagnostic test | High-risk Colon Cancer (Training), High-risk Colon Cancer (Validation), Low-risk Colon Cancer (Training), Low-risk Colon Cancer (Validation) |
Primary outcome
Pathological Stage IIB or higher patients
Time frame: At time of pathology (1year after surgery)
2 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: Up to 120 months
Overall survival (OS)
Time frame: Up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 36604116Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8.
- Background: PubMed 34048685Cardoso R, Guo F, Heisser T, Hackl M, Ihle P, De Schutter H, Van Damme N, Valerianova Z, Atanasov T, Majek O, Muzik J, Nilbert MC, Tybjerg AJ, Innos K, Magi M, Malila N, Bouvier AM, Bouvier V, Launoy G, Woronoff AS, Cariou M, Robaszkiewicz M, Delafosse P, Poncet F, Katalinic A, Walsh PM, Senore C, Rosso S, Vincerzevskiene I, Lemmens VEPP, Elferink MAG, Johannesen TB, Korner H, Pfeffer F, Bento MJ, Rodrigues J, Alves da Costa F, Miranda A, Zadnik V, Zagar T, Lopez de Munain Marques A, Marcos-Gragera R, Puigdemont M, Galceran J, Carulla M, Chirlaque MD, Ballesta M, Sundquist K, Sundquist J, Weber M, Jordan A, Herrmann C, Mousavi M, Ryzhov A, Hoffmeister M, Brenner H. Colorectal cancer incidence, mortality, and stage distribution in European countries in the colorectal cancer screening era: an international population-based study. Lancet Oncol. 2021 Jul;22(7):1002-1013. doi: 10.1016/S1470-2045(21)00199-6. Epub 2021 May 25.
- Background: PubMed 36115290Taieb J, Svrcek M, Cohen R, Basile D, Tougeron D, Phelip JM. Deficient mismatch repair/microsatellite unstable colorectal cancer: Diagnosis, prognosis and treatment. Eur J Cancer. 2022 Nov;175:136-157. doi: 10.1016/j.ejca.2022.07.020. Epub 2022 Sep 14.
- Background: PubMed 38230766Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
- Background: PubMed 39552190Burley N, Lee Y, Liu L, Gangi A, Nasseri Y, Atkins K, Zaghiyan K, Murrell Z, Osipov A, Hendifar A, Hitchins M, Gong J. ctDNA-guided adjuvant immunotherapy in colorectal cancer. Immunotherapy. 2024;16(20-22):1197-1202. doi: 10.1080/1750743X.2024.2430941. Epub 2024 Nov 17.
- Background: PubMed 41115454Tan PB, Verschoor YL, van den Berg JG, Balduzzi S, Kok NFM, Ijsselsteijn ME, Moore K, Jurdi A, Tin A, Kaptein P, van Leerdam ME, Haanen JBAG, Voest EE, de Miranda NFCC, Schumacher TN, Wessels LFA, Chalabi M. Neoadjuvant immunotherapy in mismatch-repair-proficient colon cancers. Nature. 2025 Dec;648(8094):726-735. doi: 10.1038/s41586-025-09679-4. Epub 2025 Oct 20.
- Background: PubMed 41153743Krsul D, Prenc E, Pozgaj L, Stefok D, Pongrac P, Podolski M, Radicevic AP, Karlovic D, Jerkovic A, Golcic M, Drazic I, Glavas Krsul S, Fuckar Cupic D, Erakovic Haber V, Zelic M. Diagnostic Relevance of miR-185, miR-141, and miR-21 in Colon Carcinoma: Insights into Tumor Sidedness and Reference Gene Selection. Biomedicines. 2025 Oct 10;13(10):2460. doi: 10.3390/biomedicines13102460.
- Background: PubMed 41154372Serafin M, Maka M, Szostek J, Kania I, Jablonska B, Mrowiec S. Side-Specific Prognostic Factors in Colon Cancer: A Retrospective Analysis of Right- and Left-Sided Tumors. Cancers (Basel). 2025 Oct 14;17(20):3315. doi: 10.3390/cancers17203315.
- Background: PubMed 40767870Miranda J, Torri GB, Andreia Maria da Silva M, Monjardim G, Mariussi M, Schmitt LG, Wiethan CP, Ghezzi TL, Ghezzi CLA, Altmayer S, Dias AB, Horvat N. CT diagnostic performance for preoperative staging of colon cancer: a systematic review and meta-analysis. Eur Radiol. 2026 Feb;36(2):1506-1516. doi: 10.1007/s00330-025-11850-4. Epub 2025 Aug 6.
- Background: PubMed 40848246Platt JR, Elliott F, Handley K, Magill L, Quirke P, Seymour MT, West NP, Morton D, Seligmann J, Tolan DJM. CT staging performance in an international trial of neoadjuvant chemotherapy for locally advanced colon cancer. Br J Radiol. 2025 Dec 1;98(1176):2175-2183. doi: 10.1093/bjr/tqaf217.
- Background: PubMed 41084117Gosavi R, Heriot A, Narasimhan V, Warrier SK. Perspectives of the Use of Neoadjuvant Therapy in the Management of Locally Advanced and Locally Recurrent Colon Cancer: A Bi-National Survey of Colorectal Surgeons. Asia Pac J Clin Oncol. 2025 Oct 13. doi: 10.1111/ajco.70035. Online ahead of print.
- Background: PubMed 36657089Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
- Individual participant dataSharing planned: Undecided. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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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.
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 Colon Cancer, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajay Goel, PhD (626-218-3452, ajgoel@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Stage IIB or higher patients (time frame: At time of pathology (1year after 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 NCT07255729, which also lists 15 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 7 Jul 2026.