Pancreatic Neuroendocrine TumorORACLENCT07817225
Optimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation
An observational study of Pancreatic Neuroendocrine Tumor, run by Massimo Falconi at 1 site in Italy.
Trial summary
Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are heterogeneous neoplasms of the pancreatic endocrine tissue, displaying variable clinical behavior from indolent to highly aggressive forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor
- What is being tested?
- cfDNA molecular profiling
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2026to 12 Dec 2027
- 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: The study population will include approximately 30 adult patients diagnosed with non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) whose biological samples are available through the HSR NETBank biobank. Participants will represent three distinct clinical subgroups: patients under active surveillance and patients who underwent surgical resection with a histopathological diagnosis of either indolent or aggressive disease. All included patients have provided informed consent for the use of their biological material and clinical data for research purposes.
Who may be able to join
- Age ≥18 years.
- Diagnosis of sporadic, well-differentiated, non-functioning pancreatic neuroendocrine tumor (NF-PanNET).
- Signed informed consent for the use of plasma samples stored in the "NETbank" biobank.
- Availability of pre-operative or surveillance plasma samples.
Who cannot join
- Genetic syndromes associated with NF-PanNETs (e.g., MEN1, VHL).
- Functioning PanNETs.
- Inadequate quality or quantity of circulating-free DNA (cfDNA) extracted from plasma samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation: a Retrospective Study
Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are heterogeneous neoplasms of the pancreatic endocrine tissue, displaying variable clinical behavior from indolent to highly aggressive forms. Their often asymptomatic nature and lack of reliable preoperative biomarkers make clinical management particularly challenging.
This exploratory study will investigate cell-free DNA (cfDNA) as a potential non-invasive biomarker in NF-PanNETs. cfDNA samples from approximately 30 patients, representing distinct clinical courses (active surveillance, indolent post-surgical, and aggressive post-surgical cases), will be analyzed using advanced methylome and nucleosome footprinting techniques.
The aim is to evaluate cfDNA's diagnostic and prognostic potential to improve disease monitoring and support personalized therapeutic strategies in NF-PanNET patients.
Read the detailed description
Pancreatic neuroendocrine tumors (PanNETs) are rare, heterogeneous neoplasms arising from the endocrine tissue of the pancreas. Non-functioning pancreatic neuroendocrine tumors (NF- PanNETs) have traditionally been considered rare; however, their reported incidence has significantly increased over the past two decades. Current estimates suggest that approximately 1-5% of the general population may harbor undiagnosed NF-PanNETs. Given this prevalence, there is an increasing need for reliable diagnostic tools to distinguish high-risk, aggressive tumors from benign, indolent lesions.
NF-PanNETs exhibit a wide spectrum of biological behavior, ranging from slow-growing, indolent tumors to highly aggressive variants prone to local invasion and distant metastases. However, due to their frequent asymptomatic presentation and the absence of reliable preoperative markers for tumor aggressiveness, clinical management remains challenging. Current diagnostic methods rely on imaging and invasive biopsies. However, this approach has limitations in detecting early-stage disease and assessing tumor dynamics. Indeed, it often leads to overtreatment in low-risk patients through unnecessary surgical interventions, while potentially undertreating those who might benefit from more aggressive therapeutic strategies, such as neoadjuvant therapy.
In recent years, cell-free DNA (cfDNA) has emerged as a promising non-invasive biomarker in the oncology setting, proving to be extremely useful for diagnosis, prognosis and therapeutic purposes.
In the specific context of PanNETs, there is limited research on the value of cfDNA. Despite showing encouraging results, the few existing investigations on this subject, have included only small and heterogeneous cohorts, varying primary tumor sites, stages and differentiation status.
This exploratory study will analyze cfDNA profiles from approximately 30 NF-PanNET patients (10 under active surveillance, 10 with indolent tumors post-surgery, and 10 with aggressive tumors post-surgery) using advanced methylome and nucleosome footprinting technologies. Analyses in the three patient subgroups will be compared with data from a previously characterized cohort of healthy subjects.
The goal is to assess cfDNA's diagnostic and prognostic utility, potentially offering a non-invasive tool for better disease management, monitoring and personalized patient care.
- Conditions
- Pancreatic Neuroendocrine Tumor
- Being tested
- cfDNA molecular profiling
- Keywords
- cfDNA, PanNET, prognostic signatures, biomarker, liquid biopsy
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA molecular profilingOther
Circulating-free DNA (cfDNA) will be extracted from plasma samples previously collected and currently stored at the San Raffaele Hospital (HSR) NETBank biobank. cfDNA profiling will be performed using methylome and nucleosome footprinting techniques. No therapeutic or experimental intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| histological indolent PanNET | patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of indolent disease Receives: Other: cfDNA molecular profiling | |
| histological aggressive PanNET | patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of aggressive disease Receives: Other: cfDNA molecular profiling | |
| PanNET under active surveillance | patients currently under active surveillance for small indolent pancreatic neuroendocrine tumor (PanNET) Receives: Other: cfDNA molecular profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA Molecular Profiling
To investigate the feasability of circulating-free DNA (cfDNA) assessment as a non- invasive biomarker for non-functioning pancreatic neuroendocrine tumors (NF-PanNETs). cfDNA concentrations and cfDNA epigenetic and fragmentomic signatures in plasma samples will be analysed.
Measured: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
Secondary outcomes (1)
Predictive Value of cfDNA for Tumor Aggressiveness
To correlate circulating-free DNA (cfDNA) levels with tumor aggressiveness and clinical outcomes, and to identify tissue-of-origin insights using cfDNA methylation and nucleosomal footprints.
Measured: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start12 Sep 2026
- Primary completion12 Sep 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massimo Falconi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Massimo Falconi, IRCCS San Raffaele
- Investigators
- Stefano Partelli, MD, PhD, Principal investigator, IRCCS San RaffaeleDaniela Cesana, PhD, Principal investigator, San Raffaele Telethon Institute for Gene Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817225
- Sponsor's protocol ID
- ORACLE
- Acronym
- ORACLE
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loyfer N, Magenheim J, Peretz A, Cann G, Bredno J, Klochendler A, Fox-Fisher I, Shabi-Porat S, Hecht M, Pelet T, Moss J, Drawshy Z, Amini H, Moradi P, Nagaraju S, Bauman D, Shveiky D, Porat S, Dior U, Rivkin G, Or O, Hirshoren N, Carmon E, Pikarsky A, Khalaileh A, Zamir G, Grinbaum R, Abu Gazala M, Mizrahi I, Shussman N, Korach A, Wald O, Izhar U, Erez E, Yutkin V, Samet Y, Rotnemer Golinkin D, Spalding KL, Druid H, Arner P, Shapiro AMJ, Grompe M, Aravanis A, Venn O, Jamshidi A, Shemer R, Dor Y, Glaser B, Kaplan T. A DNA methylation atlas of normal human cell types. Nature. 2023 Jan;613(7943):355-364. doi: 10.1038/s41586-022-05580-6. Epub 2023 Jan 4.
PubMed 36599988Vaisvila R, Ponnaluri VKC, Sun Z, Langhorst BW, Saleh L, Guan S, Dai N, Campbell MA, Sexton BS, Marks K, Samaranayake M, Samuelson JC, Church HE, Tamanaha E, Correa IR Jr, Pradhan S, Dimalanta ET, Evans TC Jr, Williams L, Davis TB. Enzymatic methyl sequencing detects DNA methylation at single-base resolution from picograms of DNA. Genome Res. 2021 Jul;31(7):1280-1289. doi: 10.1101/gr.266551.120. Epub 2021 Jun 17.
PubMed 34140313Cowzer D, Shah RH, Chou JF, Kundra R, Punn S, Fiedler L, DeMore A, Capanu M, Berger MF, Reidy-Lagunes D, Raj N. Clinical utility of plasma cell-free DNA in pancreatic neuroendocrine neoplasms. Endocr Relat Cancer. 2024 Mar 4;31(4):e230292. doi: 10.1530/ERC-23-0292. Print 2024 Apr 1.
PubMed 38252063Oversoe SK, Sorensen BS, Tabaksblat EM, Gronbaek H, Kelsen J. Cell-Free DNA and Clinical Characteristics in Patients with Small Intestinal or Pancreatic Neuroendocrine Tumors. Neuroendocrinology. 2022;112(1):43-50. doi: 10.1159/000514457. Epub 2021 Jan 18.
PubMed 33461190Boons G, Vandamme T, Peeters M, Beyens M, Driessen A, Janssens K, Zwaenepoel K, Roeyen G, Van Camp G, Op de Beeck K. Cell-Free DNA From Metastatic Pancreatic Neuroendocrine Tumor Patients Contains Tumor-Specific Mutations and Copy Number Variations. Front Oncol. 2018 Nov 1;8:467. doi: 10.3389/fonc.2018.00467. eCollection 2018.
PubMed 30443491Partelli S, Battistella A, Andreasi V, Muffatti F, Tamburrino D, Pecorelli N, Crippa S, Balzano G, Falconi M. Critical appraisal of the adequacy of surgical indications for non-functioning pancreatic neuroendocrine tumours. BJS Open. 2024 Jul 2;8(4):zrae083. doi: 10.1093/bjsopen/zrae083.
PubMed 39107074Partelli S, Giannone F, Schiavo Lena M, Muffatti F, Andreasi V, Crippa S, Tamburrino D, Zamboni G, Rubini C, Doglioni C, Falconi M. Is the Real Prevalence of Pancreatic Neuroendocrine Tumors Underestimated? A Retrospective Study on a Large Series of Pancreatic Specimens. Neuroendocrinology. 2019;109(2):165-170. doi: 10.1159/000499606. Epub 2019 May 22.
PubMed 31117106Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
PubMed 28448665
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07817225
- Acronym / sponsor ID
- ORACLE / ORACLE
- Conditions
- Pancreatic Neuroendocrine Tumor
- Keywords
- cfDNA, PanNET, prognostic signatures, biomarker, liquid biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massimo FalconiUniversity, hospital or other
- Study start
- 12 Sep 2026 (actual)
- Primary completion
- 12 Sep 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are heterogeneous neoplasms of the pancreatic endocrine tissue, displaying variable clinical behavior from indolent to highly aggressive forms. Their often asymptomatic nature and lack of reliable preoperative biomarkers make clinical management particularly challenging.
This exploratory study will investigate cell-free DNA (cfDNA) as a potential non-invasive biomarker in NF-PanNETs. cfDNA samples from approximately 30 patients, representing distinct clinical courses (active surveillance, indolent post-surgical, and aggressive post-surgical cases), will be analyzed using advanced methylome and nucleosome footprinting techniques.
The aim is to evaluate cfDNA's diagnostic and prognostic potential to improve disease monitoring and support personalized therapeutic strategies in NF-PanNET patients.
Detailed description
Pancreatic neuroendocrine tumors (PanNETs) are rare, heterogeneous neoplasms arising from the endocrine tissue of the pancreas. Non-functioning pancreatic neuroendocrine tumors (NF- PanNETs) have traditionally been considered rare; however, their reported incidence has significantly increased over the past two decades. Current estimates suggest that approximately 1-5% of the general population may harbor undiagnosed NF-PanNETs. Given this prevalence, there is an increasing need for reliable diagnostic tools to distinguish high-risk, aggressive tumors from benign, indolent lesions.
NF-PanNETs exhibit a wide spectrum of biological behavior, ranging from slow-growing, indolent tumors to highly aggressive variants prone to local invasion and distant metastases. However, due to their frequent asymptomatic presentation and the absence of reliable preoperative markers for tumor aggressiveness, clinical management remains challenging. Current diagnostic methods rely on imaging and invasive biopsies. However, this approach has limitations in detecting early-stage disease and assessing tumor dynamics. Indeed, it often leads to overtreatment in low-risk patients through unnecessary surgical interventions, while potentially undertreating those who might benefit from more aggressive therapeutic strategies, such as neoadjuvant therapy.
In recent years, cell-free DNA (cfDNA) has emerged as a promising non-invasive biomarker in the oncology setting, proving to be extremely useful for diagnosis, prognosis and therapeutic purposes.
In the specific context of PanNETs, there is limited research on the value of cfDNA. Despite showing encouraging results, the few existing investigations on this subject, have included only small and heterogeneous cohorts, varying primary tumor sites, stages and differentiation status.
This exploratory study will analyze cfDNA profiles from approximately 30 NF-PanNET patients (10 under active surveillance, 10 with indolent tumors post-surgery, and 10 with aggressive tumors post-surgery) using advanced methylome and nucleosome footprinting technologies. Analyses in the three patient subgroups will be compared with data from a previously characterized cohort of healthy subjects.
The goal is to assess cfDNA's diagnostic and prognostic utility, potentially offering a non-invasive tool for better disease management, monitoring and personalized patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| histological indolent PanNET | – | Other: cfDNA molecular profilingpatients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of indolent disease |
| histological aggressive PanNET | – | Other: cfDNA molecular profilingpatients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of aggressive disease |
| PanNET under active surveillance | – | Other: cfDNA molecular profilingpatients currently under active surveillance for small indolent pancreatic neuroendocrine tumor (PanNET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include approximately 30 adult patients diagnosed with non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) whose biological samples are available through the HSR NETBank biobank. Participants will represent three distinct clinical subgroups: patients under active surveillance and patients who underwent surgical resection with a histopathological diagnosis of either indolent or aggressive disease. All included patients have provided informed consent for the use of their biological material and clinical data for research purposes.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Diagnosis of sporadic, well-differentiated, non-functioning pancreatic neuroendocrine tumor (NF-PanNET).
- Signed informed consent for the use of plasma samples stored in the "NETbank" biobank.
- Availability of pre-operative or surveillance plasma samples.
Key exclusion criteria (3 listed)
- Genetic syndromes associated with NF-PanNETs (e.g., MEN1, VHL).
- Functioning PanNETs.
- Inadequate quality or quantity of circulating-free DNA (cfDNA) extracted from plasma samples.
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 |
|---|---|---|
| cfDNA molecular profilingCirculating-free DNA (cfDNA) will be extracted from plasma samples previously collected and currently stored at the San Raffaele Hospital (HSR) NETBank biobank. cfDNA profiling will be performed using methylome and nucleosome footprinting techniques. No therapeutic or experimental intervention will be performed. | Other | PanNET under active surveillance, histological aggressive PanNET, histological indolent PanNET |
Primary outcome
cfDNA Molecular Profiling
Time frame: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
To investigate the feasability of circulating-free DNA (cfDNA) assessment as a non- invasive biomarker for non-functioning pancreatic neuroendocrine tumors (NF-PanNETs). cfDNA concentrations and cfDNA epigenetic and fragmentomic signatures in plasma samples will be analysed.
1 secondary outcome
Predictive Value of cfDNA for Tumor Aggressiveness
Time frame: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
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 16 Sep 2026.
- Background: PubMed 36599988Loyfer N, Magenheim J, Peretz A, Cann G, Bredno J, Klochendler A, Fox-Fisher I, Shabi-Porat S, Hecht M, Pelet T, Moss J, Drawshy Z, Amini H, Moradi P, Nagaraju S, Bauman D, Shveiky D, Porat S, Dior U, Rivkin G, Or O, Hirshoren N, Carmon E, Pikarsky A, Khalaileh A, Zamir G, Grinbaum R, Abu Gazala M, Mizrahi I, Shussman N, Korach A, Wald O, Izhar U, Erez E, Yutkin V, Samet Y, Rotnemer Golinkin D, Spalding KL, Druid H, Arner P, Shapiro AMJ, Grompe M, Aravanis A, Venn O, Jamshidi A, Shemer R, Dor Y, Glaser B, Kaplan T. A DNA methylation atlas of normal human cell types. Nature. 2023 Jan;613(7943):355-364. doi: 10.1038/s41586-022-05580-6. Epub 2023 Jan 4.
- Background: PubMed 34140313Vaisvila R, Ponnaluri VKC, Sun Z, Langhorst BW, Saleh L, Guan S, Dai N, Campbell MA, Sexton BS, Marks K, Samaranayake M, Samuelson JC, Church HE, Tamanaha E, Correa IR Jr, Pradhan S, Dimalanta ET, Evans TC Jr, Williams L, Davis TB. Enzymatic methyl sequencing detects DNA methylation at single-base resolution from picograms of DNA. Genome Res. 2021 Jul;31(7):1280-1289. doi: 10.1101/gr.266551.120. Epub 2021 Jun 17.
- Background: PubMed 38252063Cowzer D, Shah RH, Chou JF, Kundra R, Punn S, Fiedler L, DeMore A, Capanu M, Berger MF, Reidy-Lagunes D, Raj N. Clinical utility of plasma cell-free DNA in pancreatic neuroendocrine neoplasms. Endocr Relat Cancer. 2024 Mar 4;31(4):e230292. doi: 10.1530/ERC-23-0292. Print 2024 Apr 1.
- Background: PubMed 33461190Oversoe SK, Sorensen BS, Tabaksblat EM, Gronbaek H, Kelsen J. Cell-Free DNA and Clinical Characteristics in Patients with Small Intestinal or Pancreatic Neuroendocrine Tumors. Neuroendocrinology. 2022;112(1):43-50. doi: 10.1159/000514457. Epub 2021 Jan 18.
- Background: PubMed 30443491Boons G, Vandamme T, Peeters M, Beyens M, Driessen A, Janssens K, Zwaenepoel K, Roeyen G, Van Camp G, Op de Beeck K. Cell-Free DNA From Metastatic Pancreatic Neuroendocrine Tumor Patients Contains Tumor-Specific Mutations and Copy Number Variations. Front Oncol. 2018 Nov 1;8:467. doi: 10.3389/fonc.2018.00467. eCollection 2018.
- Background: PubMed 39107074Partelli S, Battistella A, Andreasi V, Muffatti F, Tamburrino D, Pecorelli N, Crippa S, Balzano G, Falconi M. Critical appraisal of the adequacy of surgical indications for non-functioning pancreatic neuroendocrine tumours. BJS Open. 2024 Jul 2;8(4):zrae083. doi: 10.1093/bjsopen/zrae083.
- Background: PubMed 31117106Partelli S, Giannone F, Schiavo Lena M, Muffatti F, Andreasi V, Crippa S, Tamburrino D, Zamboni G, Rubini C, Doglioni C, Falconi M. Is the Real Prevalence of Pancreatic Neuroendocrine Tumors Underestimated? A Retrospective Study on a Large Series of Pancreatic Specimens. Neuroendocrinology. 2019;109(2):165-170. doi: 10.1159/000499606. Epub 2019 May 22.
- Background: PubMed 28448665Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
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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.
Stefano Partelli, MD, PhD principal investigator
IRCCS San Raffaele
Daniela Cesana, PhD principal investigator
San Raffaele Telethon Institute for Gene Therapy
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 Pancreatic Neuroendocrine Tumor, run by Massimo Falconi at 1 site in Italy.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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 Italy. 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?
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?
cfDNA Molecular Profiling (time frame: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.). 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 NCT07817225, which also lists 8 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 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.