Serum IGF-1 and IGF-1Ec in Malignancy Assessment

NCT07151807 | Active Not Recruiting

• 1 other identifier: COMU-FNO-4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study investigates the relationship between serum IGF-1 and IGF-1Ec (E-peptide/MGF) levels and tumor burden in patients with solid tumors. By analyzing serum samples using ELISA and correlating them with clinical data such as tumor stage, size, metastasis, and lymph node involvement, the study aims to explore whether these biomarkers-particularly IGF-1Ec and the IGF-1Ec/IGF-1 ratio-can reflect tumor progression and serve as potential prognostic indicators.

Conditions

Cancer; Solid Tumor Malignancies; IGF1R; Solid Cancers

Outcome Measures

Primary Outcomes (1)

• IGF-1 and IGF-1Ec levels

  Blood values

  From enrollment to 6 month

Study Arms (1)

1

The study group will consist of at least 60 adult patients (aged 18 and older) with histologically confirmed solid tumors who are clinically stable and have not yet started or are in the early phase of standard chemotherapy. Participants will be recruited from the outpatient and inpatient oncology units at Çanakkale Onsekiz Mart University. Individuals with hematological malignancies, organ failure, or conditions/medications affecting IGF-1 levels will be excluded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include approximately 100 adult patients (≥18 years old) diagnosed with histologically confirmed solid tumors. All participants will be recruited from the Çanakkale Onsekiz Mart University Oncology Outpatient Clinic or Inpatient Services. Only clinically stable patients will be included.

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed diagnosis of a solid tumor
• Clinically stable condition, prior to chemotherapy or during standard follow-up
• Ability to provide informed consent

You may not qualify if:

• Hematological malignancies (e.g., leukemia, lymphoma)
• Acute or chronic liver or kidney failure
• Current use (within 1 month) of corticosteroids, growth hormone, or medications affecting IGF-1 levels
• Pregnancy or lactation
• Coagulopathy or severe anemia preventing safe venipuncture

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, 17020, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research asistant, PhD

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 3, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-06

Locations

TU (1)