NCT06044064

Brief Summary

To assess whether EUS (Endoscopic Ultrasound) can serve as a valuable diagnostic tool for identifying PDAC at an early stage in individuals who have recently been diagnosed with diabetes. Purpose: To improve the rates of early detection of pancreatic cancer. Pancreatic ductal adenocarcinoma (PDAC) is a type of cancer that starts in the pancreas, a gland located in your abdomen. It happens when some cells in the pancreas start growing abnormally and form a cancer.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Dec 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2023Sep 2027

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

3.7 years

First QC Date

September 13, 2023

Last Update Submit

October 21, 2023

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

  • Incidence of PDAC at 3 years

    3yrs

Secondary Outcomes (1)

  • • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years

    baseline and 3yrs

Interventions

A blood sample for CA 19-9 (cancer detection test)PROCEDURE

* A blood sample for CA 19-9 (cancer detection test) levels will be taken at baseline. * Contrast CT abdomen - Pancreas protocol will be done at baseline. * EUS (Endoscopic Ultrasound) under moderate sedation will be done at baseline to you. * If suspicious lesion is found on examination, Fine Needle Aspiration - FNA will be done.

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the consecutive patients coming to OP will be screened at AIG for the study criterias, those who are meeting them, shall be enrolled after consent. Patients will enrolled for 1 year and followed up for 3 years

You may qualify if:

  • Age \> 50 years
  • Patients diagnosed with diabetes based on FBS/ PPBS/ HbA1C
  • Presence of atleast 1 FBS parameter measured in the past 6-18 months which was not \> 125 mg/dl
  • END-PDAC score \> 2

You may not qualify if:

  • Known or newly detected chronic pancreatitis
  • Past history of pancreatic cancer
  • History of steroid use
  • Contraindications for EUS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CA-19-9 Antigen

Intervention Hierarchy (Ancestors)

Antigens, Tumor-Associated, CarbohydrateAntigens, NeoplasmAntigensBiological FactorsLewis Blood Group AntigensBlood Group AntigensAntigens, SurfaceEpitopesIsoantigensBiomarkers, TumorBiomarkers

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 24, 2023

Record last verified: 2023-10