Intrahepatic Cholangiocarcinoma (Icc)EXOMICNCT07224737

Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.

An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intrahepatic Cholangiocarcinoma (Icc)
What is being tested?: EXOMIC small RNA sequencing and EXOMIC assay (qRT-PCR validation)
How many people: 230 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2024to 18 Feb 2026
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: 250

Who may be able to join

Histologically confirmed ICC (clinical stage I-III).
Undergoing curative-intent hepatectomy.
Availability of preoperative pasma or serum sample (≥200 µL).
Standard staging imaging completed per institutional protocol.
Written informed consent.

Who cannot join

Extrahepatic cholangiocarcinoma or gallbladder cancer.
Synchronous non-ICC malignancy.
Inadequate clinical follow-up.
Inability to consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91016

Other trials in United States

About this study

Official title: Machine Learning-based Exosome Liquid Biopsy Enables Stratification of Occult Metastasis Risk in Patients With Intrahepatic Cholangiocarcinoma

Occult metastasis at the time of surgery is a major driver of poor outcomes in intrahepatic cholangiocarcinoma (ICC), yet reliable preoperative biomarkers to identify such patients are lacking. The EXOMIC study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to detect occult metastasis preoperatively in patients with resectable ICC.

Read the detailed description

Intrahepatic cholangiocarcinoma (ICC) incidence is rising globally, and prognosis remains poor. Patients harboring occult micrometastases that are not detected on preoperative imaging often experience rapid recurrence and significantly worse survival. Tumor-derived exosomes contribute to pre-metastatic niche formation and carry microRNAs that reflect aggressive metastatic potential. Circulating exosomal microRNA profiles may serve as non-invasive biomarkers to reveal occult metastasis before surgery.

Preoperative exosomes will be analyzed using small RNA sequencing (discovery) followed by RT-qPCR validation and machine-learning modeling to develop a predictive score for occult metastasis. The study will evaluate diagnostic performance (sensitivity, specificity, accuracy, AUROC), prognostic relevance (OS/RFS), and clinical utility (decision curve analysis) to establish a biologically informed framework for treatment stratification in ICC.

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Being tested: EXOMIC small RNA sequencing, EXOMIC assay (qRT-PCR validation)
Keywords: Exosomal miRNA, ICC, Liquid Biopsy, Occult metastasis, Tumor recurrence, Liver cancer
Medical subject headings: Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Recurrence, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXOMIC small RNA sequencingDiagnostic test
High-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery.
Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.
EXOMIC assay (qRT-PCR validation)Diagnostic test
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.

Study groups in NCT07224737
Study group	Role	What they receive
Training Cohort - ICC with Occult Metastasis		The cohort of ICC patients who had occult metastasis detected at the time of surgery. Preoperative samples were analyzed using the EXOMIC qRT-PCR assay to validate candidate exosomal microRNAs identified in the discovery cohort. Receives: Diagnostic Test: EXOMIC assay (qRT-PCR validation)
Training Cohort - ICC without Occult Metastasis		The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection. Receives: Diagnostic Test: EXOMIC assay (qRT-PCR validation)
Validation Cohort - ICC with Occult Metastasis		The cohort of ICC patients with occult metastasis at the time of primary tumor resection. The EXOMIC qRT-PCR assay was applied to confirm the predictive value of the exosomal miRNA panel in identifying occult metastasis prior to surgery. Receives: Diagnostic Test: EXOMIC assay (qRT-PCR validation)
Validation Cohort - ICC without Occult Metastasis		The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection. Receives: Diagnostic Test: EXOMIC assay (qRT-PCR validation)
Discovery Cohort - ICC with Occult Metastasis		Patients with intrahepatic cholangiocarcinoma (ICC) who were found to have occult metastasis at the time of primary tumor resection in the discovery cohort. Preoperative samples were analyzed using small RNA sequencing to identify exosome-derived microRNAs associated with the presence of occult metastasis. Receives: Diagnostic Test: EXOMIC small RNA sequencing
Discovery Cohort - ICC without Occult Metastasis		Patients with ICC who had no occult metastasis at the time of primary tumor resection in the discovery cohort. Preoperative samples from these patients were analyzed by small RNA sequencing and compared with those from patients with occult metastasis to identify candidate microRNAs. Receives: Diagnostic Test: EXOMIC small RNA sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

Recurrence Free Survival
The time period from surgery to recurrence of ICC.
Measured: 3 years

Secondary outcomes (1)

Overall Survival
Time from surgery to death from any cause
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202418 Feb 2026

First posted5 Nov 2025
Study start21 Jun 2024
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 (13)Papers the sponsor has linked to this study.
Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies 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: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07224737
Sponsor's protocol ID: 23228/EXOMIC
Acronym: EXOMIC
Status last verified: Mar 2026
First submitted: 3 Nov 2025
Last updated: 13 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Huang G, Zhang H, Yang Z, Li Q, Yuan H, Chen P, Xie C, Meng B, Zhang X, Chen K, Yu H. Predictive value of HTS grade in patients with intrahepatic cholangiocarcinoma undergoing radical resection: a multicenter study from China. World J Surg Oncol. 2024 Jan 11;22(1):17. doi: 10.1186/s12957-023-03281-6.
PubMed 38200585
Swanson K, Wu E, Zhang A, Alizadeh AA, Zou J. From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment. Cell. 2023 Apr 13;186(8):1772-1791. doi: 10.1016/j.cell.2023.01.035. Epub 2023 Mar 10.
PubMed 36905928
Kojima T, Umeda Y, Fuji T, Niguma T, Sato D, Endo Y, Sui K, Inagaki M, Oishi M, Ota T, Hioki K, Matsuda T, Aoki H, Hirai R, Kimura M, Yagi T, Fujiwara T. Efficacy of surgical management for recurrent intrahepatic cholangiocarcinoma: A multi-institutional study by the Okayama Study Group of HBP surgery. PLoS One. 2020 Sep 3;15(9):e0238392. doi: 10.1371/journal.pone.0238392. eCollection 2020.
PubMed 32881910
Feng J, Liang B, Zhang HY, Liu Z, Jiang K, Zhao XQ. Prognostic factors for patients with mass-forming intrahepatic cholangiocarcinoma: A case series of 68 patients. World J Gastrointest Surg. 2022 May 27;14(5):442-451. doi: 10.4240/wjgs.v14.i5.442.
PubMed 35734620
Doussot A, Gonen M, Wiggers JK, Groot-Koerkamp B, DeMatteo RP, Fuks D, Allen PJ, Farges O, Kingham TP, Regimbeau JM, D'Angelica MI, Azoulay D, Jarnagin WR. Recurrence Patterns and Disease-Free Survival after Resection of Intrahepatic Cholangiocarcinoma: Preoperative and Postoperative Prognostic Models. J Am Coll Surg. 2016 Sep;223(3):493-505.e2. doi: 10.1016/j.jamcollsurg.2016.05.019. Epub 2016 Jun 11.
PubMed 27296525
Yu TH, Chen X, Zhang XH, Zhang EC, Sun CX. Clinicopathological characteristics and prognostic factors for intrahepatic cholangiocarcinoma: a population-based study. Sci Rep. 2021 Feb 17;11(1):3990. doi: 10.1038/s41598-021-83149-5.
PubMed 33597569
Clements O, Eliahoo J, Kim JU, Taylor-Robinson SD, Khan SA. Risk factors for intrahepatic and extrahepatic cholangiocarcinoma: A systematic review and meta-analysis. J Hepatol. 2020 Jan;72(1):95-103. doi: 10.1016/j.jhep.2019.09.007. Epub 2019 Sep 16.
PubMed 31536748
Bertuccio P, Malvezzi M, Carioli G, Hashim D, Boffetta P, El-Serag HB, La Vecchia C, Negri E. Global trends in mortality from intrahepatic and extrahepatic cholangiocarcinoma. J Hepatol. 2019 Jul;71(1):104-114. doi: 10.1016/j.jhep.2019.03.013. Epub 2019 Mar 23.
PubMed 30910538
An L, Zheng R, Zhang S, Chen R, Wang S, Sun K, Lu L, Zhang X, Zhao H, Zeng H, Wei W, He J. Hepatocellular carcinoma and intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in China: estimates based on data from 188 population-based cancer registries. Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55. doi: 10.21037/hbsn-21-75. Epub 2021 Jul 21.
PubMed 36860251
Sirica AE, Strazzabosco M, Cadamuro M. Intrahepatic cholangiocarcinoma: Morpho-molecular pathology, tumor reactive microenvironment, and malignant progression. Adv Cancer Res. 2021;149:321-387. doi: 10.1016/bs.acr.2020.10.005. Epub 2020 Dec 9.
PubMed 33579427
Fiste O, Ntanasis-Stathopoulos I, Gavriatopoulou M, Liontos M, Koutsoukos K, Dimopoulos MA, Zagouri F. The Emerging Role of Immunotherapy in Intrahepatic Cholangiocarcinoma. Vaccines (Basel). 2021 Apr 22;9(5):422. doi: 10.3390/vaccines9050422.
PubMed 33922362
Zhang R, Wang Z, Yang M, Chen B, Liu M, Zheng M, Liu PX, Wang L. Combining traditional analysis and machine learning to predict early, middle, and long-term recurrence of intrahepatic cholangiocarcinoma. Eur J Surg Oncol. 2025 Sep;51(9):110141. doi: 10.1016/j.ejso.2025.110141. Epub 2025 May 9.
PubMed 40446770
Zhao B, Cheng Q, Cao H, Zhou X, Li T, Dong L, Wang W. Dynamic change of serum CA19-9 levels in benign and malignant patients with obstructive jaundice after biliary drainage and new correction formulas. BMC Cancer. 2021 May 7;21(1):517. doi: 10.1186/s12885-021-08204-w.
PubMed 33962560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Machine Learning-based Exosome Liquid Biopsy Enables Stratification of Occult Metastasis Risk in Patients With Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT07224737
Acronym / sponsor ID: EXOMIC / 23228/EXOMIC
Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Keywords: Exosomal miRNA, ICC, Liquid Biopsy, Occult metastasis, Tumor recurrence, Liver cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Study start: 21 Jun 2024 (actual)
Primary completion: 18 Jan 2026 (actual)
Study completion: 18 Feb 2026 (actual)
First posted: 5 Nov 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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 6

Arm	Type	Receives
Training Cohort - ICC with Occult Metastasis	–	Diagnostic Test: EXOMIC assay (qRT-PCR validation)The cohort of ICC patients who had occult metastasis detected at the time of surgery. Preoperative samples were analyzed using the EXOMIC qRT-PCR assay to validate candidate exosomal microRNAs identified in the discovery cohort.
Training Cohort - ICC without Occult Metastasis	–	Diagnostic Test: EXOMIC assay (qRT-PCR validation)The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection.
Validation Cohort - ICC with Occult Metastasis	–	Diagnostic Test: EXOMIC assay (qRT-PCR validation)The cohort of ICC patients with occult metastasis at the time of primary tumor resection. The EXOMIC qRT-PCR assay was applied to confirm the predictive value of the exosomal miRNA panel in identifying occult metastasis prior to surgery.
Validation Cohort - ICC without Occult Metastasis	–	Diagnostic Test: EXOMIC assay (qRT-PCR validation)The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection.
Discovery Cohort - ICC with Occult Metastasis	–	Diagnostic Test: EXOMIC small RNA sequencingPatients with intrahepatic cholangiocarcinoma (ICC) who were found to have occult metastasis at the time of primary tumor resection in the discovery cohort. Preoperative samples were analyzed using small RNA sequencing to identify exosome-derived microRNAs associated with the presence of occult metastasis.
Discovery Cohort - ICC without Occult Metastasis	–	Diagnostic Test: EXOMIC small RNA sequencingPatients with ICC who had no occult metastasis at the time of primary tumor resection in the discovery cohort. Preoperative samples from these patients were analyzed by small RNA sequencing and compared with those from patients with occult metastasis to identify candidate microRNAs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 250

Key inclusion criteria (5 listed)

Histologically confirmed ICC (clinical stage I-III).
Undergoing curative-intent hepatectomy.
Availability of preoperative pasma or serum sample (≥200 µL).
Standard staging imaging completed per institutional protocol.
Written informed consent.

Key exclusion criteria (4 listed)

Extrahepatic cholangiocarcinoma or gallbladder cancer.
Synchronous non-ICC malignancy.
Inadequate clinical follow-up.
Inability to consent.

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
EXOMIC small RNA sequencingHigh-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery. Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.	Diagnostic test	Discovery Cohort - ICC with Occult Metastasis, Discovery Cohort - ICC without Occult Metastasis
EXOMIC assay (qRT-PCR validation)Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing. This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.	Diagnostic test	Training Cohort - ICC with Occult Metastasis, Training Cohort - ICC without Occult Metastasis, Validation Cohort - ICC with Occult Metastasis, Validation Cohort - ICC without Occult Metastasis

Primary outcome

Recurrence Free Survival
Time frame: 3 years
The time period from surgery to recurrence of ICC.

1 secondary outcome

Overall Survival
Time frame: 5 years

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 38200585Huang G, Zhang H, Yang Z, Li Q, Yuan H, Chen P, Xie C, Meng B, Zhang X, Chen K, Yu H. Predictive value of HTS grade in patients with intrahepatic cholangiocarcinoma undergoing radical resection: a multicenter study from China. World J Surg Oncol. 2024 Jan 11;22(1):17. doi: 10.1186/s12957-023-03281-6.
Background: PubMed 36905928Swanson K, Wu E, Zhang A, Alizadeh AA, Zou J. From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment. Cell. 2023 Apr 13;186(8):1772-1791. doi: 10.1016/j.cell.2023.01.035. Epub 2023 Mar 10.
Background: PubMed 32881910Kojima T, Umeda Y, Fuji T, Niguma T, Sato D, Endo Y, Sui K, Inagaki M, Oishi M, Ota T, Hioki K, Matsuda T, Aoki H, Hirai R, Kimura M, Yagi T, Fujiwara T. Efficacy of surgical management for recurrent intrahepatic cholangiocarcinoma: A multi-institutional study by the Okayama Study Group of HBP surgery. PLoS One. 2020 Sep 3;15(9):e0238392. doi: 10.1371/journal.pone.0238392. eCollection 2020.
Background: PubMed 35734620Feng J, Liang B, Zhang HY, Liu Z, Jiang K, Zhao XQ. Prognostic factors for patients with mass-forming intrahepatic cholangiocarcinoma: A case series of 68 patients. World J Gastrointest Surg. 2022 May 27;14(5):442-451. doi: 10.4240/wjgs.v14.i5.442.
Background: PubMed 27296525Doussot A, Gonen M, Wiggers JK, Groot-Koerkamp B, DeMatteo RP, Fuks D, Allen PJ, Farges O, Kingham TP, Regimbeau JM, D'Angelica MI, Azoulay D, Jarnagin WR. Recurrence Patterns and Disease-Free Survival after Resection of Intrahepatic Cholangiocarcinoma: Preoperative and Postoperative Prognostic Models. J Am Coll Surg. 2016 Sep;223(3):493-505.e2. doi: 10.1016/j.jamcollsurg.2016.05.019. Epub 2016 Jun 11.
Background: PubMed 33597569Yu TH, Chen X, Zhang XH, Zhang EC, Sun CX. Clinicopathological characteristics and prognostic factors for intrahepatic cholangiocarcinoma: a population-based study. Sci Rep. 2021 Feb 17;11(1):3990. doi: 10.1038/s41598-021-83149-5.
Background: PubMed 31536748Clements O, Eliahoo J, Kim JU, Taylor-Robinson SD, Khan SA. Risk factors for intrahepatic and extrahepatic cholangiocarcinoma: A systematic review and meta-analysis. J Hepatol. 2020 Jan;72(1):95-103. doi: 10.1016/j.jhep.2019.09.007. Epub 2019 Sep 16.
Background: PubMed 30910538Bertuccio P, Malvezzi M, Carioli G, Hashim D, Boffetta P, El-Serag HB, La Vecchia C, Negri E. Global trends in mortality from intrahepatic and extrahepatic cholangiocarcinoma. J Hepatol. 2019 Jul;71(1):104-114. doi: 10.1016/j.jhep.2019.03.013. Epub 2019 Mar 23.
Background: PubMed 36860251An L, Zheng R, Zhang S, Chen R, Wang S, Sun K, Lu L, Zhang X, Zhao H, Zeng H, Wei W, He J. Hepatocellular carcinoma and intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in China: estimates based on data from 188 population-based cancer registries. Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55. doi: 10.21037/hbsn-21-75. Epub 2021 Jul 21.
Background: PubMed 33579427Sirica AE, Strazzabosco M, Cadamuro M. Intrahepatic cholangiocarcinoma: Morpho-molecular pathology, tumor reactive microenvironment, and malignant progression. Adv Cancer Res. 2021;149:321-387. doi: 10.1016/bs.acr.2020.10.005. Epub 2020 Dec 9.
Background: PubMed 33922362Fiste O, Ntanasis-Stathopoulos I, Gavriatopoulou M, Liontos M, Koutsoukos K, Dimopoulos MA, Zagouri F. The Emerging Role of Immunotherapy in Intrahepatic Cholangiocarcinoma. Vaccines (Basel). 2021 Apr 22;9(5):422. doi: 10.3390/vaccines9050422.
Background: PubMed 40446770Zhang R, Wang Z, Yang M, Chen B, Liu M, Zheng M, Liu PX, Wang L. Combining traditional analysis and machine learning to predict early, middle, and long-term recurrence of intrahepatic cholangiocarcinoma. Eur J Surg Oncol. 2025 Sep;51(9):110141. doi: 10.1016/j.ejso.2025.110141. Epub 2025 May 9.
Individual participant dataSharing planned: No. 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. 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 Intrahepatic Cholangiocarcinoma (Icc), 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?

Recurrence Free Survival (time frame: 3 years). 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 NCT07224737, which also lists 13 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.