Intrahepatic Cholangiocarcinoma (Icc)LUMICNCT07225452
An Exosomal miRNA-based Liquid Biopsy for ICC Detection
An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by City of Hope Medical Center at 1 site in United States.
Trial summary
Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- Small RNA sequencing and LUMIC assay
- How many people
- 535 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 5 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals diagnosed with intrahepatic cholangiocarcinoma and control participants (non-cancer or benign biliary disease) with available pre-treatment plasma samples.
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed intrahepatic cholangiocarcinoma
- Availability of pre-treatment plasma sample
- Informed consent provided
Who cannot join
- Extrahepatic cholangiocarcinoma
- History of other malignancy within 5 years
- Active infection, autoimmune disease, or pregnancy
- Inadequate clinical data or poor sample quality
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91016
About this study
Official title: Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection
Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need.
The LUMIC study aims to develop a non-invasive liquid biopsy platform based on both exosomal microRNAs (exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.
Read the detailed description
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy after hepatocellular carcinoma, accounting for approximately 10-15% of all primary liver cancers. Despite improvements in surgical techniques and imaging modalities, ICC is often diagnosed at advanced stages, resulting in dismal outcomes with a 5-year overall survival rate of 25-30%.
Traditional imaging approaches such as CT and MRI have limited sensitivity for detecting early or small ICC lesions. Blood-based biomarkers, including CA19-9, also lack adequate specificity.
Recent advances in liquid biopsy have demonstrated that exosomal microRNAs (exo-miRNAs) can serve as promising, minimally invasive biomarkers reflecting tumor biology and microenvironmental changes.
The LUMIC study (Liquid biopsy Using exosomal miRNA for Intrahepatic Cholangiocarcinoma detection) aims to identify and validate miRNA signatures capable of distinguishing ICC from benign biliary or non-cancerous liver conditions.
Blood samples are collected before treatment, and exo-miRNA expression profiles are analyzed using RT-qPCR and bioinformatic pipelines. Diagnostic performance (AUC, sensitivity, specificity) will be evaluated through training and validation cohorts.
This study provides a foundation for integrating liquid biopsy-based diagnostics into ICC clinical workflows to enable earlier detection and improved treatment stratification.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- Small RNA sequencing, LUMIC assay
- Keywords
- ICC, Exosome, microRNA, miRNA, liquid biopsy, liver cancer
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small RNA sequencingDiagnostic test
Small RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs
LUMIC assayDiagnostic test
RT-qPCR validation of selected miRNAs
| Study group | Role | What they receive |
|---|---|---|
| Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq) | Serum and plasma samples from patients with histologically confirmed ICC will be analyzed using small RNA sequencing to identify circulating miRNAs specifically upregulated in ICC. These miRNAs will serve as candidates for downstream validation. Receives: Diagnostic Test: Small RNA sequencing | |
| Non-disease Control (Discovery, Small RNA-seq) | Serum and plasma samples from individuals without malignant or inflammatory liver diseases (benign or healthy controls) will be analyzed in parallel by small RNA sequencing to identify miRNAs differentially expressed between ICC and non-disease controls. Receives: Diagnostic Test: Small RNA sequencing | |
| Intrahepatic Cholangiocarcinoma (Training) | Patients with histologically confirmed ICC whose pre-treatment serum or plasma samples will be used to construct and optimize the exo-miRNA diagnostic panel based on discovery-phase candidates. Receives: Diagnostic Test: LUMIC assay | |
| Non-disease Control (Training) | Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will serve as controls to establish baseline miRNA expression and diagnostic thresholds. Receives: Diagnostic Test: LUMIC assay | |
| Intrahepatic Cholangiocarcinoma (Validation) | Independent ICC cohort used for external validation of the LUMIC assay to confirm diagnostic performance and reproducibility. Receives: Diagnostic Test: LUMIC assay | |
| Non-disease Control (Validation) | Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will be used for validation of specificity and model robustness. Receives: Diagnostic Test: LUMIC assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The proportion of true positive ICC cases correctly identified by the LUMIC assay.
Measured: Through study completion (~1 year)
Secondary outcomes (2)
Specificity
The proportion of true negative cases correctly classified as non-ICC.
Measured: Through study completion (~1 year)
Diagnostic accuracy (AUC)
The overall discriminative ability of the exo-miRNA panel for ICC detection.
Measured: Through study completion (~1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start21 Jun 2024
- Primary completion5 Jan 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- 535 participants (actual)
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
- NCT07225452
- Sponsor's protocol ID
- 23228/LUMIC
- Acronym
- LUMIC
- Status last verified
- Mar 2026
- First submitted
- 4 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
Li J, Bao H, Huang Z, Liang Z, Lin N, Ni C, Xu Y. Non-Coding RNA in Cholangiocarcinoma: An Update. Front Biosci (Landmark Ed). 2023 Aug 18;28(8):173. doi: 10.31083/j.fbl2808173.
PubMed 37664914Sato K, Glaser S, Alvaro D, Meng F, Francis H, Alpini G. Cholangiocarcinoma: novel therapeutic targets. Expert Opin Ther Targets. 2020 Apr;24(4):345-357. doi: 10.1080/14728222.2020.1733528. Epub 2020 Feb 26.
PubMed 32077341Luo C, Xin H, Zhou Z, Hu Z, Sun R, Yao N, Sun Q, Borjigin U, Wu X, Fan J, Huang X, Zhou S, Zhou J. Tumor-derived exosomes induce immunosuppressive macrophages to foster intrahepatic cholangiocarcinoma progression. Hepatology. 2022 Oct;76(4):982-999. doi: 10.1002/hep.32387. Epub 2022 Feb 28.
PubMed 35106794Li Z, Shen J, Chan MT, Wu WK. The role of microRNAs in intrahepatic cholangiocarcinoma. J Cell Mol Med. 2017 Jan;21(1):177-184. doi: 10.1111/jcmm.12951. Epub 2016 Sep 13.
PubMed 27619971Wada Y, Shimada M, Morine Y, Ikemoto T, Saito Y, Baba H, Mori M, Goel A. A blood-based noninvasive miRNA signature for predicting survival outcomes in patients with intrahepatic cholangiocarcinoma. Br J Cancer. 2022 May;126(8):1196-1204. doi: 10.1038/s41416-022-01710-z. Epub 2022 Jan 25.
PubMed 35079106Liu L, Shi Y, Zhang P, Zhang X. Integration analysis of miRNA-mRNA expression exploring their potential roles in intrahepatic cholangiocarcinoma. Sci Rep. 2023 May 24;13(1):8362. doi: 10.1038/s41598-023-35288-0.
PubMed 37225858European Association for the Study of the Liver. EASL-ILCA Clinical Practice Guidelines on the management of intrahepatic cholangiocarcinoma. J Hepatol. 2023 Jul;79(1):181-208. doi: 10.1016/j.jhep.2023.03.010. Epub 2023 Apr 20.
PubMed 37084797Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, Pawlik TM, Gores GJ. Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol. 2014 Jun;60(6):1268-89. doi: 10.1016/j.jhep.2014.01.021. Epub 2014 Mar 27. No abstract available.
PubMed 24681130Moris D, Palta M, Kim C, Allen PJ, Morse MA, Lidsky ME. Advances in the treatment of intrahepatic cholangiocarcinoma: An overview of the current and future therapeutic landscape for clinicians. CA Cancer J Clin. 2023 Mar;73(2):198-222. doi: 10.3322/caac.21759. Epub 2022 Oct 19.
PubMed 36260350Tovar-Camargo OA, Toden S, Goel A. Exosomal microRNA Biomarkers: Emerging Frontiers in Colorectal and Other Human Cancers. Expert Rev Mol Diagn. 2016;16(5):553-67. doi: 10.1586/14737159.2016.1156535. Epub 2016 Mar 16.
PubMed 26892862Sui S, Xu C, Kanda M, Okugawa Y, Toiyama Y, Park JO, Hur H, Kim SC, Taketomi A, Kodera Y, Cheng X, Li M, Goel A. Exosomal Liquid Biopsy for the Early Detection of Gastric Cancer: The DESTINEX Multicenter Study. JAMA Surg. 2025 Sep 1;160(9):973-982. doi: 10.1001/jamasurg.2025.2493.
PubMed 40737022Nakamura K, Zhu Z, Roy S, Jun E, Han H, Munoz RM, Nishiwada S, Sharma G, Cridebring D, Zenhausern F, Kim S, Roe DJ, Darabi S, Han IW, Evans DB, Yamada S, Demeure MJ, Becerra C, Celinski SA, Borazanci E, Tsai S, Kodera Y, Park JO, Bolton JS, Wang X, Kim SC, Von Hoff D, Goel A. An Exosome-based Transcriptomic Signature for Noninvasive, Early Detection of Patients With Pancreatic Ductal Adenocarcinoma: A Multicenter Cohort Study. Gastroenterology. 2022 Nov;163(5):1252-1266.e2. doi: 10.1053/j.gastro.2022.06.090. Epub 2022 Jul 16.
PubMed 35850192
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
- Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection
- ClinicalTrials.gov ID
- NCT07225452
- Acronym / sponsor ID
- LUMIC / 23228/LUMIC
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Keywords
- ICC, Exosome, microRNA, miRNA, liquid biopsy, liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 6 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.
Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need.
The LUMIC study aims to develop a non-invasive liquid biopsy platform based on both exosomal microRNAs (exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.
Detailed description
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy after hepatocellular carcinoma, accounting for approximately 10-15% of all primary liver cancers. Despite improvements in surgical techniques and imaging modalities, ICC is often diagnosed at advanced stages, resulting in dismal outcomes with a 5-year overall survival rate of 25-30%.
Traditional imaging approaches such as CT and MRI have limited sensitivity for detecting early or small ICC lesions. Blood-based biomarkers, including CA19-9, also lack adequate specificity.
Recent advances in liquid biopsy have demonstrated that exosomal microRNAs (exo-miRNAs) can serve as promising, minimally invasive biomarkers reflecting tumor biology and microenvironmental changes.
The LUMIC study (Liquid biopsy Using exosomal miRNA for Intrahepatic Cholangiocarcinoma detection) aims to identify and validate miRNA signatures capable of distinguishing ICC from benign biliary or non-cancerous liver conditions.
Blood samples are collected before treatment, and exo-miRNA expression profiles are analyzed using RT-qPCR and bioinformatic pipelines. Diagnostic performance (AUC, sensitivity, specificity) will be evaluated through training and validation cohorts.
This study provides a foundation for integrating liquid biopsy-based diagnostics into ICC clinical workflows to enable earlier detection and improved treatment stratification.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq) | – | Diagnostic Test: Small RNA sequencingSerum and plasma samples from patients with histologically confirmed ICC will be analyzed using small RNA sequencing to identify circulating miRNAs specifically upregulated in ICC. These miRNAs will serve as candidates for downstream validation. |
| Non-disease Control (Discovery, Small RNA-seq) | – | Diagnostic Test: Small RNA sequencingSerum and plasma samples from individuals without malignant or inflammatory liver diseases (benign or healthy controls) will be analyzed in parallel by small RNA sequencing to identify miRNAs differentially expressed between ICC and non-disease controls. |
| Intrahepatic Cholangiocarcinoma (Training) | – | Diagnostic Test: LUMIC assayPatients with histologically confirmed ICC whose pre-treatment serum or plasma samples will be used to construct and optimize the exo-miRNA diagnostic panel based on discovery-phase candidates. |
| Non-disease Control (Training) | – | Diagnostic Test: LUMIC assayIndividuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will serve as controls to establish baseline miRNA expression and diagnostic thresholds. |
| Intrahepatic Cholangiocarcinoma (Validation) | – | Diagnostic Test: LUMIC assayIndependent ICC cohort used for external validation of the LUMIC assay to confirm diagnostic performance and reproducibility. |
| Non-disease Control (Validation) | – | Diagnostic Test: LUMIC assayIndividuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will be used for validation of specificity and model robustness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with intrahepatic cholangiocarcinoma and control participants (non-cancer or benign biliary disease) with available pre-treatment plasma samples.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Histologically confirmed intrahepatic cholangiocarcinoma
- Availability of pre-treatment plasma sample
- Informed consent provided
Key exclusion criteria (4 listed)
- Extrahepatic cholangiocarcinoma
- History of other malignancy within 5 years
- Active infection, autoimmune disease, or pregnancy
- Inadequate clinical data or poor sample quality
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 |
|---|---|---|
| Small RNA sequencingSmall RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs | Diagnostic test | Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq), Non-disease Control (Discovery, Small RNA-seq) |
| LUMIC assayRT-qPCR validation of selected miRNAs | Diagnostic test | Intrahepatic Cholangiocarcinoma (Training), Intrahepatic Cholangiocarcinoma (Validation), Non-disease Control (Training), Non-disease Control (Validation) |
Primary outcome
Sensitivity
Time frame: Through study completion (~1 year)
The proportion of true positive ICC cases correctly identified by the LUMIC assay.
2 secondary outcomes
Specificity
Time frame: Through study completion (~1 year)
Diagnostic accuracy (AUC)
Time frame: Through study completion (~1 year)
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 37664914Li J, Bao H, Huang Z, Liang Z, Lin N, Ni C, Xu Y. Non-Coding RNA in Cholangiocarcinoma: An Update. Front Biosci (Landmark Ed). 2023 Aug 18;28(8):173. doi: 10.31083/j.fbl2808173.
- Background: PubMed 32077341Sato K, Glaser S, Alvaro D, Meng F, Francis H, Alpini G. Cholangiocarcinoma: novel therapeutic targets. Expert Opin Ther Targets. 2020 Apr;24(4):345-357. doi: 10.1080/14728222.2020.1733528. Epub 2020 Feb 26.
- Background: PubMed 35106794Luo C, Xin H, Zhou Z, Hu Z, Sun R, Yao N, Sun Q, Borjigin U, Wu X, Fan J, Huang X, Zhou S, Zhou J. Tumor-derived exosomes induce immunosuppressive macrophages to foster intrahepatic cholangiocarcinoma progression. Hepatology. 2022 Oct;76(4):982-999. doi: 10.1002/hep.32387. Epub 2022 Feb 28.
- Background: PubMed 27619971Li Z, Shen J, Chan MT, Wu WK. The role of microRNAs in intrahepatic cholangiocarcinoma. J Cell Mol Med. 2017 Jan;21(1):177-184. doi: 10.1111/jcmm.12951. Epub 2016 Sep 13.
- Background: PubMed 35079106Wada Y, Shimada M, Morine Y, Ikemoto T, Saito Y, Baba H, Mori M, Goel A. A blood-based noninvasive miRNA signature for predicting survival outcomes in patients with intrahepatic cholangiocarcinoma. Br J Cancer. 2022 May;126(8):1196-1204. doi: 10.1038/s41416-022-01710-z. Epub 2022 Jan 25.
- Background: PubMed 37225858Liu L, Shi Y, Zhang P, Zhang X. Integration analysis of miRNA-mRNA expression exploring their potential roles in intrahepatic cholangiocarcinoma. Sci Rep. 2023 May 24;13(1):8362. doi: 10.1038/s41598-023-35288-0.
- Background: PubMed 37084797European Association for the Study of the Liver. EASL-ILCA Clinical Practice Guidelines on the management of intrahepatic cholangiocarcinoma. J Hepatol. 2023 Jul;79(1):181-208. doi: 10.1016/j.jhep.2023.03.010. Epub 2023 Apr 20.
- Background: PubMed 24681130Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, Pawlik TM, Gores GJ. Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol. 2014 Jun;60(6):1268-89. doi: 10.1016/j.jhep.2014.01.021. Epub 2014 Mar 27. No abstract available.
- Background: PubMed 36260350Moris D, Palta M, Kim C, Allen PJ, Morse MA, Lidsky ME. Advances in the treatment of intrahepatic cholangiocarcinoma: An overview of the current and future therapeutic landscape for clinicians. CA Cancer J Clin. 2023 Mar;73(2):198-222. doi: 10.3322/caac.21759. Epub 2022 Oct 19.
- Background: PubMed 26892862Tovar-Camargo OA, Toden S, Goel A. Exosomal microRNA Biomarkers: Emerging Frontiers in Colorectal and Other Human Cancers. Expert Rev Mol Diagn. 2016;16(5):553-67. doi: 10.1586/14737159.2016.1156535. Epub 2016 Mar 16.
- Background: PubMed 40737022Sui S, Xu C, Kanda M, Okugawa Y, Toiyama Y, Park JO, Hur H, Kim SC, Taketomi A, Kodera Y, Cheng X, Li M, Goel A. Exosomal Liquid Biopsy for the Early Detection of Gastric Cancer: The DESTINEX Multicenter Study. JAMA Surg. 2025 Sep 1;160(9):973-982. doi: 10.1001/jamasurg.2025.2493.
- Background: PubMed 35850192Nakamura K, Zhu Z, Roy S, Jun E, Han H, Munoz RM, Nishiwada S, Sharma G, Cridebring D, Zenhausern F, Kim S, Roe DJ, Darabi S, Han IW, Evans DB, Yamada S, Demeure MJ, Becerra C, Celinski SA, Borazanci E, Tsai S, Kodera Y, Park JO, Bolton JS, Wang X, Kim SC, Von Hoff D, Goel A. An Exosome-based Transcriptomic Signature for Noninvasive, Early Detection of Patients With Pancreatic Ductal Adenocarcinoma: A Multicenter Cohort Study. Gastroenterology. 2022 Nov;163(5):1252-1266.e2. doi: 10.1053/j.gastro.2022.06.090. Epub 2022 Jul 16.
- 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 4 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?
Sensitivity (time frame: Through study completion (~1 year)). 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 NCT07225452, which also lists 12 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; AzTrials last refreshed its copy on 2 Nov 2026.