Head and Neck CancerHNCsNCT06529588
Estimation of (suPAR) in Chronic Periodontitis With Post-radiotherapy on HNCs Patients
An observational study of Head and Neck Cancer and Chronic Periodontitis, run by Al-Maarif University College at 1 site in Iraq.
Trial summary
This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT). Read more about this study
- Who is it for?
- Ages 28 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Chronic Periodontitis, Radiotherapy Side Effect
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2022to 23 Oct 2023
- 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 28 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was n=26 nasopharyngeal tumors (n=20 nonkeratinizing and n=6 keratinizing carcinomas), (n=6 oropharyngeal squamous cell carcinoma, SCC), (n=8 Laryngeal cancer), (n=6 tongue cancer), and (n=4 primary malignancies of unclear origin). Twenty-eight of the patients (or 56%) had a concomitant systemic therapy (2-3 doses) of cisplatin or cetuximab in addition to radiotherapy. Chronic periodontitis patients without HNCs included: Patients' average ages ranged from 28 to 65 years, with 40 (80%) of them being male. More than half of them had a history of smoking, with 31 (62%) and 5 (10) of them having used alcohol. A control group was used periodontally healthy as a controlled study, the mean age was 40.12 years (min-max: 29-60 years).
Who may be able to join
- A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
- Not having received radiation therapy previously.
- No distant metastasis.
- No history of salivary gland surgery (parotid, submandibular, or sublingual).
- A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.
Who cannot join
- Previous oral disease or salivary gland disease history.
- Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soluble Urokinase Plasminogen Activator Receptor (suPAR) is a Potential Biomarker of Stage III-IV, Grade C Periodontitis Through the Impact of Post-radiotherapy on Head and Neck Cancer Patients
This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).
Read the detailed description
The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels.
- Being tested
- Radiation
- Keywords
- Chronic Periodontitis, Head and Neck Cancer, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Chronic Periodontitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Also called Head and neck cancer patients after 6 irradiation
HNCs patients who received radiotherapy was exposure (5700-7000 Gys) for fractions number (32-35) after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer post-radiotherapy | Head and Neck cancer patients who received radiotherapy (32-35 fractions) exposure (5700-7000 Gys) addition chemotherapy (cisplatin or cetuximab (2-3 dosages). Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of serum suPAR level
Measure of serum suPAR level in patients head and neck cancer who received radiotherapy
Measured: 6 months
Clinical Periodontal parameters measured
Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.
Measured: 6 months
Secondary outcomes (1)
Oral pH-saliva was measured
Oral pH-saliva collected from outcomes and measured pH-saliva by using pH-meter in patients who underwent radiotherapy.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Sep 2022
- Primary completion9 Jan 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Maarif University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A. Al-Kubaisi, PhD, Study director, Al-Maarif University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529588
- Sponsor's protocol ID
- suPAR as a potential biomarker
- Acronym
- HNCs
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.
PubMed 35304084Gasparoni LM, Alves FA, Holzhausen M, Pannuti CM, Serpa MS. Periodontitis as a risk factor for head and neck cancer. Med Oral Patol Oral Cir Bucal. 2021 Jul 1;26(4):e430-e436. doi: 10.4317/medoral.24270.
PubMed 33340075Al-Kubaisi AA, Ghazi MA, Majeed NS, Aldelaimi ER, Enezei HH. Soluble urokinase plasminogen activator receptor (suPAR) is a potential biomarker of stage III-IV, grade C periodontitis through the impact of post-radiotherapy on head and neck cancer patients. BMC Oral Health. 2024 Sep 27;24(1):1144. doi: 10.1186/s12903-024-04801-w.
PubMed 39334335
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Urokinase Plasminogen Activator Receptor (suPAR) is a Potential Biomarker of Stage III-IV, Grade C Periodontitis Through the Impact of Post-radiotherapy on Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06529588
- Acronym / sponsor ID
- HNCs / suPAR as a potential biomarker
- Keywords
- Chronic Periodontitis, Head and Neck Cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Al-Maarif University CollegeUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 31 Jul 2024 (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 study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).
Detailed description
The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer post-radiotherapy | – | Radiation: RadiationHead and Neck cancer patients who received radiotherapy (32-35 fractions) exposure (5700-7000 Gys) addition chemotherapy (cisplatin or cetuximab (2-3 dosages). |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was n=26 nasopharyngeal tumors (n=20 nonkeratinizing and n=6 keratinizing carcinomas), (n=6 oropharyngeal squamous cell carcinoma, SCC), (n=8 Laryngeal cancer), (n=6 tongue cancer), and (n=4 primary malignancies of unclear origin). Twenty-eight of the patients (or 56%) had a concomitant systemic therapy (2-3 doses) of cisplatin or cetuximab in addition to radiotherapy. Chronic periodontitis patients without HNCs included: Patients' average ages ranged from 28 to 65 years, with 40 (80%) of them being male. More than half of them had a history of smoking, with 31 (62%) and 5 (10) of them having used alcohol. A control group was used periodontally healthy as a controlled study, the mean age was 40.12 years (min-max: 29-60 years).
Key inclusion criteria (5 listed)
- A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
- Not having received radiation therapy previously.
- No distant metastasis.
- No history of salivary gland surgery (parotid, submandibular, or sublingual).
- A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.
Key exclusion criteria (3 listed)
- Previous oral disease or salivary gland disease history.
- Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
- Refusal to participate in the study.
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 |
|---|---|---|
| RadiationAlso: Head and neck cancer patients after 6 irradiationHNCs patients who received radiotherapy was exposure (5700-7000 Gys) for fractions number (32-35) after 6 months | Radiation | Head and neck cancer post-radiotherapy |
Primary outcome
Measure of serum suPAR level
Time frame: 6 months
Measure of serum suPAR level in patients head and neck cancer who received radiotherapy
Clinical Periodontal parameters measured
Time frame: 6 months
Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.
1 secondary outcome
Oral pH-saliva was measured
Time frame: 6 month
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 31 Jul 2024.
- Background: PubMed 35304084Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.
- Results publication: PubMed 33340075Gasparoni LM, Alves FA, Holzhausen M, Pannuti CM, Serpa MS. Periodontitis as a risk factor for head and neck cancer. Med Oral Patol Oral Cir Bucal. 2021 Jul 1;26(4):e430-e436. doi: 10.4317/medoral.24270.
- Derived from this study: PubMed 39334335Al-Kubaisi AA, Ghazi MA, Majeed NS, Aldelaimi ER, Enezei HH. Soluble urokinase plasminogen activator receptor (suPAR) is a potential biomarker of stage III-IV, grade C periodontitis through the impact of post-radiotherapy on head and neck cancer patients. BMC Oral Health. 2024 Sep 27;24(1):1144. doi: 10.1186/s12903-024-04801-w.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A. Al-Kubaisi, PhD study director
Al-Maarif University College
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 Head and Neck Cancer and Chronic Periodontitis, run by Al-Maarif University College at 1 site in Iraq.
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 5 inclusion and 3 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 31 Jul 2024. 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 Iraq. 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?
Measure of serum suPAR level (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529588, which also lists 3 linked publications.
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 31 Jul 2024.