Larynx CancerNCT05217147
An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma
An observational study of Larynx Cancer and Larynx Carcinoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Larynx Cancer, Larynx Carcinoma
- What is being tested?
- Obtaining blood samples
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study included 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients.
Who may be able to join
- 60 male or female patients with a newly diagnosed laryngeal squamous cell carcinoma
- Patients without any previous history of laryngeal carcinoma
- 20 healthy, age- and sex- matched controls
Who cannot join
- Previous history of laryngeal squamous cell carcinoma
- Having comorbid systemic diseases like DM, hypertension, cardiologic or rheumatologic diseases
- Having malign tumors elsewhere
- History of chemotherapy/radiotherapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Cancer Institute
Ankara, 06100
About this study
Official title: An Investigation of Clinical Parameters and Biomarkers Associated With Angiogenesis, Proliferation, Cell Adhesion and Invasion in Laryngeal Carcinoma
The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.
Read the detailed description
Although there has been a significant increase in survival in many other cancer types through the years, no significant increase has been achieved in laryngeal SCC survival rates in the last 50 years. Despite the advancements in surgical techniques, organ preservation protocols and multidisciplinary approach, significant amount of patients have been living with morbidity or dying due to recurrence and metastasis. This lack of significant improvement in mortality rates creates the need for reliable and accurate biomarkers in early diagnosis, treatment and follow-up. Considering that the prognosis of two patients at the same clinical stage and treated with the same treatment protocol may differ, it suggests that there may be some differences at the molecular level apart from clinical stages.
This study was mainly prepared to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.
To reach these aims, 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey, and were diagnosed with LSCC between May 2018 and February 2020. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients. Serum samples were obtained from all participants at the time of diagnosis, centrifuged and stored at -80 C. ELISA method will be used to analyze the serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin.
Data analysis will reveal if there are any association between biomarker candidate molecules and clinical parameters.
- Conditions
- Larynx Cancer, Larynx Carcinoma
- Being tested
- Obtaining blood samples
- Keywords
- larynx carcinoma, angiogenin, endoglin, vegf, svegfr-1, vegfr-2, osteoponitn, biomarker
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtaining blood samplesOther
Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | 60 patients with laryngeal carcinoma Receives: Other: Obtaining blood samples | |
| Control group | 20 healthy age- and sex- matched controls Receives: Other: Obtaining blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of biomarker candidate molecules
Serum levels of:
VEGF in pg/ml
sVEGFR1 in pg/ml
VEGFR2 in pg/ml
IGFBP-3 in pg/ml
angiogenin in pg/ml
and endoglin in pg/ml
will be determined in all participants
Measured: Basal
Stage
Disease stage as stage as early (I-II) or late (III-IV)
Measured: Basal
Diagnostic sensitivity and specifity of biomarker candidate molecules
Receiver operating characteristic analysis will be performed to determine a significant level of any biomarker candidate molecules for diagnostic sensitivity and sensitivity.
Sensitivity and specifity as percentages (%)
Measured: Basal
Tumor grade
Tumor grade as poor, moderate or well
Measured: Basal
Recurrence status
Recurrence status as yer or no
Measured: 18 months after reaching the target patient number
Tumor localization
Tumor localization as glottic/supraglottic or transglottic
Measured: Basal
Treatment modality
Treatment modality as surgical, non-surgical or combined
Measured: Basal
Secondary outcomes (1)
Survival analysis parameters
All the patients were contacted for survival analysis.
Overall and disease-free survival will be measured in months and survival rates will be calculated in percentages (%).
Overall survival and disease-free survival rates will be calculated according to levels of biomarker candidate molecules and assessed for any association with any molecule.
Measured: 18 months after reaching the target patient number
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 May 2018
- Primary completion1 Feb 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurcan GUNAYDIN, MD, PhD, Hacettepe University
- Investigators
- Gurcan Gunaydin, MD, PhD, Principal investigator, Hacettepe University Cancer InstituteNilda Suslu, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217147
- Sponsor's protocol ID
- THD-2019-18414
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Clinical Parameters and Biomarkers Associated With Angiogenesis, Proliferation, Cell Adhesion and Invasion in Laryngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05217147
- Acronym / sponsor ID
- THD-2019-18414
- Conditions
- Larynx Cancer, Larynx Carcinoma
- Keywords
- larynx carcinoma, angiogenin, endoglin, vegf, svegfr-1, vegfr-2, osteoponitn, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 1 Feb 2022 (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.
The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.
Detailed description
Although there has been a significant increase in survival in many other cancer types through the years, no significant increase has been achieved in laryngeal SCC survival rates in the last 50 years. Despite the advancements in surgical techniques, organ preservation protocols and multidisciplinary approach, significant amount of patients have been living with morbidity or dying due to recurrence and metastasis. This lack of significant improvement in mortality rates creates the need for reliable and accurate biomarkers in early diagnosis, treatment and follow-up. Considering that the prognosis of two patients at the same clinical stage and treated with the same treatment protocol may differ, it suggests that there may be some differences at the molecular level apart from clinical stages.
This study was mainly prepared to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.
To reach these aims, 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey, and were diagnosed with LSCC between May 2018 and February 2020. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients. Serum samples were obtained from all participants at the time of diagnosis, centrifuged and stored at -80 C. ELISA method will be used to analyze the serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin.
Data analysis will reveal if there are any association between biomarker candidate molecules and clinical parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Obtaining blood samples60 patients with laryngeal carcinoma |
| Control group | – | Other: Obtaining blood samples20 healthy age- and sex- matched controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients.
Key inclusion criteria (3 listed)
- 60 male or female patients with a newly diagnosed laryngeal squamous cell carcinoma
- Patients without any previous history of laryngeal carcinoma
- 20 healthy, age- and sex- matched controls
Key exclusion criteria (4 listed)
- Previous history of laryngeal squamous cell carcinoma
- Having comorbid systemic diseases like DM, hypertension, cardiologic or rheumatologic diseases
- Having malign tumors elsewhere
- History of chemotherapy/radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtaining blood samplesBlood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules. | Other | Control group, Patient group |
Primary outcome
Serum levels of biomarker candidate molecules
Time frame: Basal
Serum levels of: VEGF in pg/ml sVEGFR1 in pg/ml VEGFR2 in pg/ml IGFBP-3 in pg/ml angiogenin in pg/ml and endoglin in pg/ml will be determined in all participants
Stage
Time frame: Basal
Disease stage as stage as early (I-II) or late (III-IV)
Diagnostic sensitivity and specifity of biomarker candidate molecules
Time frame: Basal
Receiver operating characteristic analysis will be performed to determine a significant level of any biomarker candidate molecules for diagnostic sensitivity and sensitivity. Sensitivity and specifity as percentages (%)
Tumor grade
Time frame: Basal
Tumor grade as poor, moderate or well
Recurrence status
Time frame: 18 months after reaching the target patient number
Recurrence status as yer or no
Tumor localization
Time frame: Basal
Tumor localization as glottic/supraglottic or transglottic
Treatment modality
Time frame: Basal
Treatment modality as surgical, non-surgical or combined
1 secondary outcome
Survival analysis parameters
Time frame: 18 months after reaching the target patient number
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Gurcan Gunaydin, MD, PhD principal investigator
Hacettepe University Cancer Institute
Nilda Suslu study chair
Hacettepe University
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 Larynx Cancer and Larynx Carcinoma, run by Hacettepe 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum levels of biomarker candidate molecules (time frame: Basal). The study lists 7 primary outcomes in all. 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 22 Sep 2023.