Oral Cancer Clinical Trial
Official title:
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06031337 -
Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
|
||
Completed |
NCT00158678 -
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
|
Phase 3 | |
Completed |
NCT00933387 -
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
|
Phase 2 | |
Enrolling by invitation |
NCT05030597 -
Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
|
N/A | |
Recruiting |
NCT03684707 -
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
|
Phase 4 | |
Recruiting |
NCT06130332 -
Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)
|
Phase 2 | |
Recruiting |
NCT04372914 -
Prevention of Oral DNA Damage by Black Raspberries
|
N/A | |
Active, not recruiting |
NCT03529422 -
Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN
|
Phase 2 | |
Recruiting |
NCT03686020 -
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
|
||
Not yet recruiting |
NCT06060288 -
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
|
||
Withdrawn |
NCT00951470 -
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT00964977 -
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
|
Phase 3 | |
Completed |
NCT01418118 -
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
|
Phase 4 | |
Active, not recruiting |
NCT00232960 -
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
|
N/A | |
Recruiting |
NCT05429099 -
Mandibular Reconstruction Preplanning (ViPMR)
|
Phase 2/Phase 3 | |
Completed |
NCT04614896 -
Use of Ultrasound for Measuring Size of Oral Tongue Cancers
|
N/A | |
Recruiting |
NCT03685409 -
Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions
|
Phase 3 | |
Completed |
NCT00402779 -
Erlotinib Prevention of Oral Cancer (EPOC)
|
Phase 3 | |
Recruiting |
NCT05153733 -
Improved Implant for Reconstruction Purposes After Mandibular Resection
|
N/A | |
Recruiting |
NCT02960724 -
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
|
Phase 2 |