NCT03338166

Brief Summary

Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

June 17, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

June 17, 2017

Last Update Submit

November 7, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum LDH level as a predictor of response in hepatocellular carcinoma

    To evaluate if serum LDH level can be used as a predictor of response in patients receiving different lines of treatment for hepatocellular carcinoma

    2 months

Study Arms (4)

Group A

Patients with Hepatocellular carcinoma who treated with sorafenib and measure LDH serum level one month pre and post treatment

Other: LDH serum level

Group B

Patients with Hepatocellular carcinoma who treated with trans catheter arterial chemo embolization (TACE) and measure LDH serum level one month pre and post treatment

Other: LDH serum level

Group C

Patients with Hepatocellular carcinoma who treated surgically and measure LDH serum level one month pre and post treatment

Other: LDH serum level

Group D

Patients with Hepatocellular carcinoma who don't receive treatment and asses LDH serum level for 3months

Other: LDH serum level

Interventions

Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome

Group AGroup BGroup CGroup D

Eligibility Criteria

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

Patients resident at oncology department at luxor international hospital who diagnosed as apatient with Hepatocellular carcinoma

You may qualify if:

  • patients with Hepatocellular carcinoma diagnosed by biopsy or imaging criteria and alpha feto protein.
  • signed informed consent before registration in study
  • Eastern Cooperative oncology Groups Performance status between 0 and 2.

You may not qualify if:

  • Cachexia or poor condition
  • pregnant or human chorionic gonadotropin positive
  • patient with another liver tumor
  • Any previous treatment

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

Study Officials

  • Aml R Ibrahim, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir S Mohammed, Professor

CONTACT

Marwa I Khalaf, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2017

First Posted

November 9, 2017

Study Start

January 2, 2018

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11