NCT04524650

Brief Summary

Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 20, 2020

Last Update Submit

August 26, 2020

Conditions

Gastroesophageal VaricesColorectal CancerReceived Oxaliplatin-based Chemotherapy

Keywords

portal hypertensionsplenomegalycolorectal carcinomaoxaliplatinhepatotoxicity

Outcome Measures

Primary Outcomes (1)

  • the severity of portal hypertension

    High portal pressure

    1 day (the same time as diagnosis)

Study Arms (4)

stage 0

without liver function injury or splenomegaly

Diagnostic Test: the level of vWF

stage 1

occurrence of liver function injury (ALT or AST \> 2 ULN (upper limit of normal)

Diagnostic Test: the level of vWF

stage 2

occurrence of splenomegaly or reduced platelet count (\<150 X10\^9/L)

Diagnostic Test: the level of vWF

stage 3

occurrence of portal hypertension and/or gastroesophageal varices

Diagnostic Test: the level of vWF

Interventions

the level of vWFDIAGNOSTIC_TEST

the peripheral level of vWF

stage 0stage 1stage 2stage 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had a history of colorectal cancer and received oxaliplatin-based chemotherapy

You may qualify if:

  • Male or female patients aged 18-75
  • Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;

You may not qualify if:

  • Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
  • With colorectal cancer required further anti-tumor treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • Huang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7.

    PMID: 32380558RESULT

  • Aloia T, Sebagh M, Plasse M, Karam V, Levi F, Giacchetti S, Azoulay D, Bismuth H, Castaing D, Adam R. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin Oncol. 2006 Nov 1;24(31):4983-90. doi: 10.1200/JCO.2006.05.8156.

    PMID: 17075116RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsHypertension, PortalSplenomegaly

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoquan HUANG

CONTACT

008618801733835huang.xiaoquan@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 24, 2020

Study Start

August 31, 2020

Primary Completion

October 31, 2021

Study Completion

September 30, 2022

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

CN(1)