NCT06042842

Brief Summary

  1. 1.To evaluate the clinical utility of plasma circRNAs (hsa\_circ\_0004001) as a non invasive diagnostic biomarker for HCC patients and to differentiate between malignant and nonmalignant hepatic disorders.
  2. 2.To study the relation of circRNAs (hsa\_circ\_0004001) to HCC staging.
  3. 3.To compare between circRNAs (hsa\_circ\_0004001) and the routine marker (AFP) as biomarkers for HCC diagnosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

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

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 12, 2023

Last Update Submit

October 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • (1) To evaluate the clinical utility of plasma circRNAs (hsa_circ_0004001)by Q-PCR as a non invasive diagnostic biomarker for HCC patients and to differentiate between malignant and nonmalignant hepatic disorders

    1. To evaluate the clinical utility of plasma circRNAs (hsa\_circ\_0004001) by Q-PCR as a non invasive diagnostic biomarker for HCC patients and to differentiate between malignant and nonmalignant hepatic disorders 2. To study the relation of circRNAs (hsa\_circ\_0004001) to HCC staging. 3. To compare between circRNAs (hsa\_circ\_0004001) and the routine marker (AFP) as biomarkers for HCC diagnosis

    baseline

Study Arms (3)

group 1

healthy control

group 2

patient with hepatic cell carcinoma

group 3

patient with non malignant liver diseased

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

(102 )individuals aged (18 years to 80years), did not receive any chemotherapy or surgical treatment The study will be carried out on patients who will be admitted to gastroenterology department at Assiut University hospital, and will be conducted at clinical pathology department, Assiut University Hospital, Faculty of medicine, Assiut University

You may qualify if:

  • group one patients early diagnosed as HCC
  • group two patient diagnosed with chronic non-malignant liver disease 3 group three healthy control group

You may not qualify if:

  • Patients with any other type of malignant or benign tumors should be excluded from our study.
  • History of chemotherapy or surgical treatment of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Marwa A shafeik, msc

CONTACT

Amal A mohamed, pdf

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
msc of clinical batology

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

October 4, 2023

Record last verified: 2023-09