An observational study in Oral Cancer, Oral Lichen Planus and Oral Leukoplakia, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Cairo University · Observational
Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a).
Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016).
This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's planned enrollment of 69 is below the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Leukoplakia, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mouth Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy.
Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy.
Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history
Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue .
Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy.
Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.
Diagnostic Test: Salivary Gamma-synuclein · Diagnostic Test: Incisional biopsy · Diagnostic Test: Conventional visual and tactile examination
patients diagnosed clinically and histopathologically with oral potentially malignant lesions who have not yet to receive treatment or had a month wash-out period from any previous treatment.
Diagnostic Test: Salivary Gamma-synuclein · Diagnostic Test: Incisional biopsy · Diagnostic Test: Conventional visual and tactile examination
healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history
Diagnostic Test: Salivary Gamma-synuclein · Diagnostic Test: Conventional visual and tactile examination
Gamma-synuclein salivary levels measured using ELISA assay
A) Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute. B) Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region.
Conventional visual and tactile examination using light and mirror
Gamma-synuclein level sensitivity and specificity
Measured using ELISA reader
Time frame: At same time as biopsy
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2021; primary completion for Dec 2021, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.