Oral CancerNCT03682562
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
An observational study of Oral Cancer and Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia
- What is being tested?
- DNA Integrity Index
- Type of treatment
- Pill or oral medicine
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2019to 10 Mar 2020
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: Group I: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically as having oral cancer. Group II: (History and Clinical examination) Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination(National Institute of Dental and Craniofacial Research, 2013b) have: * No visible oral lesions on conventional oral examination . * Good oral hygiene. Group III: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically with oral lichen planus as stated by modified WHO criteria (van der Meij and van der Waal, 2003).
Who may be able to join
- No visible oral lesions as detected by conventional oral examination
- Good oral hygiene, with healthy gingival tissues
- Non-smokers
- No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
Read the detailed description
As stated by the U.S. Preventive Services Task Force and the National Institute of Dental and Craniofacial Research, the main screening test for oral cancer remains conventional oral examination of the oral cavity. Most cases of oral cancer are preceded by a clinically visible lesion. These lesions are called oral potentially malignant disorders. These are leukoplakia, erythroplakia, oral submucous fibrosis, oral lichen planus and discoid lupus erythematosis. Leukoplakia has a reported annual transformation rate of 2-3%, while OLP has a rate of 0.5% .
Full thickness tissue biopsy is the "gold standard" for diagnosing suspicious lesions should they be encountered during COE. However, oral biopsy is an invasive technique that can be challenging in sites as the floor of the mouth or the soft palate . The invasive nature of a biopsy also makes it unsuitable for cancer screening in high-risk populations.
Thus there is a need for a diagnostic aid that can help primary care providers determine which patients need to be biopsied or referred to a specialist.
Nucleic acids can be released actively or passively into the circulation by both living and dead cells, where the latter is considered the predominant source. Programmed cell death gives neatly digested DNA fragments of approximately 180 bp in length. In case of solid tumors, cell-free DNA is released through necrosis which generates longer DNA fragments due to haphazard and incomplete digestion of DNA. Thus, the integrity of the DNA fragment can determine its origin making DNA integrity a potential marker for oral cancer.
The DNA integrity index (DII) is the ratio between the longer DNA fragments to the shorter ones. A higher index has been reported in breast, prostate, liver and cervical cancer. Jiang et al. 2006 found that the DNA integrity index was significantly higher in oral cancer patients than in normal ones and reported a sensitivity and specificity values of 84.5% 83% respectively . The next step for such a marker would be early quantification of performance in clinical settings to determine if it is possible to extrapolate cut off values.
- Conditions
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia
- Being tested
- DNA Integrity Index
- Medical subject headings
- Mouth Neoplasms, Lichen Planus, Oral, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Integrity IndexDiagnostic test
This test will be performed for ALL three groups:
Sample collection:
Patients will be given a sterile cup containing 5mL saline solution with which they will vigorously rinse their mouth while rubbing their tongues against the oral mucosa for 30 seconds, then spit it back into the cup. The solution will then be used for DNA extraction.
DNA integrity analysis:
The DNA integrity will be done through measuring a housekeeping gene using competitive polymerase chain reaction where the isolated DNA will be combined with DNA capture probes for sequence-specific DNA fragments. The DNA integrity index will be calculated as the ratio of the concentration of longer DNA fragments to the ratio of shorter ones.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer | Patients diagnosed clinically and histopathologically as having oral cancer. Receives: Diagnostic Test: DNA Integrity Index | |
| Premalignant Oral Lesions | Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria Receives: Diagnostic Test: DNA Integrity Index | |
| Normal Subjects | Patients who give a history of:
* No smoking
* No alcohol
* No systemic disease; and who on conventional oral examination have:
* No visible oral lesions on conventional oral examination .
* Good oral hygiene. Receives: Diagnostic Test: DNA Integrity Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in DNA Integrity Index
The DNA integrity will be compared between the three group to determine whether there is a difference between them in that aspect or not
Measured: 1 month after the end of patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start15 Sep 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Adel Azab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682562
- Sponsor's protocol ID
- N1P1H1D1
- Status last verified
- Jul 2020
- First submitted
- 21 Sep 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to the mode of data entry, if it is solely numerical it can be more easily shared and deposited on repositories, however patient clinical photos may not be possible to share
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
- ClinicalTrials.gov ID
- NCT03682562
- Acronym / sponsor ID
- N1P1H1D1
- Conditions
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 24 Sep 2018 (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 identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
Detailed description
As stated by the U.S. Preventive Services Task Force and the National Institute of Dental and Craniofacial Research, the main screening test for oral cancer remains conventional oral examination of the oral cavity. Most cases of oral cancer are preceded by a clinically visible lesion. These lesions are called oral potentially malignant disorders. These are leukoplakia, erythroplakia, oral submucous fibrosis, oral lichen planus and discoid lupus erythematosis. Leukoplakia has a reported annual transformation rate of 2-3%, while OLP has a rate of 0.5% .
Full thickness tissue biopsy is the "gold standard" for diagnosing suspicious lesions should they be encountered during COE. However, oral biopsy is an invasive technique that can be challenging in sites as the floor of the mouth or the soft palate . The invasive nature of a biopsy also makes it unsuitable for cancer screening in high-risk populations.
Thus there is a need for a diagnostic aid that can help primary care providers determine which patients need to be biopsied or referred to a specialist.
Nucleic acids can be released actively or passively into the circulation by both living and dead cells, where the latter is considered the predominant source. Programmed cell death gives neatly digested DNA fragments of approximately 180 bp in length. In case of solid tumors, cell-free DNA is released through necrosis which generates longer DNA fragments due to haphazard and incomplete digestion of DNA. Thus, the integrity of the DNA fragment can determine its origin making DNA integrity a potential marker for oral cancer.
The DNA integrity index (DII) is the ratio between the longer DNA fragments to the shorter ones. A higher index has been reported in breast, prostate, liver and cervical cancer. Jiang et al. 2006 found that the DNA integrity index was significantly higher in oral cancer patients than in normal ones and reported a sensitivity and specificity values of 84.5% 83% respectively . The next step for such a marker would be early quantification of performance in clinical settings to determine if it is possible to extrapolate cut off values.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer | – | Diagnostic Test: DNA Integrity IndexPatients diagnosed clinically and histopathologically as having oral cancer. |
| Premalignant Oral Lesions | – | Diagnostic Test: DNA Integrity IndexPatients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria |
| Normal Subjects | – | Diagnostic Test: DNA Integrity IndexPatients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination have: * No visible oral lesions on conventional oral examination . * Good oral hygiene. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Group I: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically as having oral cancer. Group II: (History and Clinical examination) Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination(National Institute of Dental and Craniofacial Research, 2013b) have: * No visible oral lesions on conventional oral examination . * Good oral hygiene. Group III: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically with oral lichen planus as stated by modified WHO criteria (van der Meij and van der Waal, 2003).
Key inclusion criteria (4 listed)
- No visible oral lesions as detected by conventional oral examination
- Good oral hygiene, with healthy gingival tissues
- Non-smokers
- No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DNA Integrity IndexThis test will be performed for ALL three groups: Sample collection: Patients will be given a sterile cup containing 5mL saline solution with which they will vigorously rinse their mouth while rubbing their tongues against the oral mucosa for 30 seconds, then spit it back into the cup. The solution will then be used for DNA extraction. DNA integrity analysis: The DNA integrity will be done through measuring a housekeeping gene using competitive polymerase chain reaction where the isolated DNA will be combined with DNA capture probes for sequence-specific DNA fragments. The DNA integrity index will be calculated as the ratio of the concentration of longer DNA fragments to the ratio of shorter ones. | Diagnostic test | Normal Subjects, Oral Cancer, Premalignant Oral Lesions |
Primary outcome
Difference in DNA Integrity Index
Time frame: 1 month after the end of patient recruitment
The DNA integrity will be compared between the three group to determine whether there is a difference between them in that aspect or not
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 15 Jul 2020.
- Individual participant dataSharing planned: Undecided. According to the mode of data entry, if it is solely numerical it can be more easily shared and deposited on repositories, however patient clinical photos may not be possible to share
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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.
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 Oral Cancer and Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
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 0 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 15 Jul 2020. 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 Egypt. 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?
Difference in DNA Integrity Index (time frame: 1 month after the end of patient recruitment). 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 15 Jul 2020.