NCT04598984

Brief Summary

It has been shown that adipokines (resistin, leptin, adiponectin) secreted from adipose tissue and proinflammatory cytokines such as IL-6, TNF-a are associated with the risk of developing colorectal cancer. However, the role of these factors in predicting clinical response to neoadjuvant therapy in rectal cancers is unknown. In this study, the role of serum adipokine levels before neoadjuvant therapy in predicting clinical response in patients with rectal cancer is investigated. For this purpose, blood will be drawn from patients with rectal cancer who will receive neoadjuvant therapy, serum adipokines will be studied and clinical response to neoadjuvant therapy will be compared.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

October 9, 2020

Last Update Submit

August 5, 2022

Conditions

Rectal Cancer Stage III

Keywords

rectal cancerneoadjuvantserum adipokinesleptinadiponectin

Outcome Measures

Primary Outcomes (1)

  • The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer

    The Adiponectin, Adipsin, Leptin, Resistin levels will be measured with flow cytometric analysis.

    1 year

Study Arms (2)

Low levels of serum adipokines

Diagnostic Test: serum adipokines

High levels of serum adipokines

Diagnostic Test: serum adipokines

Interventions

serum adipokinesDIAGNOSTIC_TEST

Level of serum adipokines will be measured with flow cytometry

High levels of serum adipokinesLow levels of serum adipokines

Eligibility Criteria

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

All patients with locally advanced rectal cancer

You may qualify if:

  • All patients with locally advanced rectal cancer

You may not qualify if:

  • below 18 years old
  • patients who did not received neoadjuvant therapyAll

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34029, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Cihad Tatar, MD

CONTACT

+905336599889tatarcihad@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 22, 2020

Study Start

September 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

TU(1)