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

• Sponsor: Istanbul Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04598984
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Stage III	Diagnostic Test: serum adipokines

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Low levels of serum adipokines	Diagnostic Test: serum adipokines; Level of serum adipokines will be measured with flow cytometry
High levels of serum adipokines	Diagnostic Test: serum adipokines; Level of serum adipokines will be measured with flow cytometry

Outcome Measures

Primary Outcome Measures

1. The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• All patients with locally advanced rectal cancer

Exclusion Criteria:

• below 18 years old

• patients who did not received neoadjuvant therapyAll

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Training and Research Hospital	Istanbul		Turkey	34029

Sponsors and Collaborators

• Istanbul Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cihad Tatar, Associate Profesor, Istanbul Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04598984
• Other Study ID Numbers: 2506
• First Posted: Oct 22, 2020
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cihad Tatar, Associate Profesor, Istanbul Training and Research Hospital: rectal cancer; neoadjuvant; serum adipokines; leptin; adiponectin
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Aug 8, 2022