Evaluation of Serum IGF-1 and IGF-1Ec (E-peptide/MGF) Levels and Their Association With Tumor Burden in Patients With Solid Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- IGF-1 and IGF-1Ec levels
Study Overview
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.
Detailed Description
Background: Insulin-like Growth Factor-1 (IGF-1) and its splice variant IGF-1Ec (also known as Mechano Growth Factor, MGF) play critical roles in cell proliferation, survival, and tumor progression. Recent evidence suggests that IGF-1Ec may act independently of the classical IGF-1 receptor pathway and contribute to aggressive tumor behavior. However, data on serum IGF-1Ec levels and their correlation with clinical tumor burden remain limited.
Objective
This cross-sectional analytical study aims to quantify serum IGF-1 and IGF-1Ec levels in patients with solid tumors and investigate their association with tumor burden parameters such as clinical stage, tumor size, lymph node involvement, and metastasis. The IGF-1Ec/IGF-1 ratio will also be evaluated as a potential prognostic biomarker.
Methods: Serum samples will be collected from approximately 60 patients diagnosed with solid tumors. IGF-1 and IGF-1Ec levels will be measured using validated ELISA kits. Clinical tumor burden will be assessed from medical records (TNM staging, metastasis, tumor diameter). Statistical analysis will include group comparisons and correlation tests.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
IGF-1 and IGF-1Ec levels
Time Frame: From enrollment to 6 month
Blood values
Secondary Outcomes
No secondary outcomes reported
Investigators
Cemre Aydeğer
Research asistant, PhD
Çanakkale Onsekiz Mart University