CancerSIGMANCT07151807
Serum IGF-1 and IGF-1Ec in Malignancy Assessment
An observational study of Cancer and Solid Tumor Malignancies, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor Malignancies, IGF1R
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, 17020
About this study
Official title: Evaluation of Serum IGF-1 and IGF-1Ec (E-peptide/MGF) Levels and Their Association With Tumor Burden in Patients With Solid Tumors
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.
Read the 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.
- Conditions
- Cancer, Solid Tumor Malignancies, IGF1R, Solid Cancers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 and IGF-1Ec levels
Blood values
Measured: From enrollment to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Aydeğer, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151807
- Sponsor's protocol ID
- COMU-FNO-4
- Acronym
- SIGMA
- Status last verified
- Jun 2025
- First submitted
- 31 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum IGF-1 and IGF-1Ec (E-peptide/MGF) Levels and Their Association With Tumor Burden in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07151807
- Acronym / sponsor ID
- SIGMA / COMU-FNO-4
- Conditions
- Cancer, Solid Tumor Malignancies, IGF1R, Solid Cancers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGF-1 and IGF-1Ec levels
Time frame: From enrollment to 6 month
Blood values
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor Malignancies, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 and IGF-1Ec levels (time frame: From enrollment to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.