NCT05275075

Brief Summary

The purpose of this study is to determine the proportion of pancreatic patients who experience weight loss and cachexia, and to identify any differences in the genes between patient groups.

Trial Health

77
On Track

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
36mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Dec 2022May 2029

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

March 2, 2022

Last Update Submit

January 6, 2026

Conditions

Keywords

pancreatic cancercachexiamicroRNAmRNAPDAC

Outcome Measures

Primary Outcomes (1)

  • Proportion of African American pancreatic cancer patients with weight loss and cachexia.

    Evaluate weight loss and the markers of cachexia, albumin and psoas cross-sectional area, to see if African Americans with pancreatic cancer patients experience Grade I-IV cachexia at a higher frequency than other racial groups.

    1 - 12 months

Secondary Outcomes (2)

  • Differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery.

    1 - 12 months

  • Differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups.

    1 - 12 months

Study Arms (1)

Pancreatic Cancer Cohort

All eligible adenocarcinoma pancreatic cancer patients with operable cancer.

Other: Pancreatic cancer microRNA and messenger RNA expression.

Interventions

Tumor specimens from pancreatic patients will be analyzed for markers associated with muscle loss.

Pancreatic Cancer Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is inclusive of all races, ethnicities, and gender. Enrollment into the study is restricted to Stephenson Cancer Center site, part of the University Oklahoma Health Sciences Center.

You may qualify if:

  • Male or female patient, who is ≥ 18 years old at the time of informed consent.
  • Patients with operable pancreatic tumors diagnosed in the last 12 months prior to consent with clinical discretion or pathology confirmed as adenocarcinoma.
  • Patient has stage I or higher disease who is considered a candidate for surgical resection of pancreatic cancer, with or without neoadjuvant chemotherapy.
  • Ability to provide written informed consent and HIPAA authorization.

You may not qualify if:

  • Patients with pancreatic adenocarcinoma who do not meet the criteria for surgical resection.
  • Patient has cancer diagnosis other than primary pancreatic adenocarcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

After surgical removal of the pancreatic cancer, part of the tumor tissue will be collected to analyze genes and RNA related to muscle loss in patients with pancreatic tumors. A portion of the tumor will be archived in a repository for future use related to this study.

MeSH Terms

Conditions

Pancreatic NeoplasmsCachexia

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Ajay Jain, MD

    University of Oklahoma Stephenson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

December 7, 2022

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2029

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations