Identification of Biomarkers for Detection of Cancer of the Oral Cavity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To assess the epigenetic and proteomic alterations in participants with OCC and identify potential biomarkers
研究概览
简要总结
Early detection and management is an emerging paradigm to reduce cancer mortality by shifting the stage of diagnosis of most cancer types to an earlier stage when they still might be curable Despite the dramatic progress and development of successful therapies for cancer treatment over the past decades cancer remains the second leading cause of death globally accounting for almost one in six deaths Cancer mortality is exacerbated by late stage diagnosis especially in developing countries like India where more than two thirds of the cancer patients are already in an advanced and incurable stage at the time of diagnosis One major goal in cancer research is the detection of cancers before they metastasize to distant sites or develop drug resistance. Even when metastasis has initiated but is not yet evident radiologically cancers can be cured in up to 50 percent of cases with systemic therapies such as cytotoxic drugs and immunotherapy. Therefore earlier detection is critical for increasing the rates of survival and at significantly lower costs of treatment.
A liquid biopsy LB test primarily relies on measuring one or more circulating analytes shed by the tumour cells in the blood. These analytes include cell-free nucleic acids cfDNA or cfRNA protein biomarkers . and other biomolecules such as glycosaminoglycans . Such tests could be supplemented with other specialized medical imaging tests such as lose dose CT or PET CT to increase the sensitivity and specificity of cancer detection at an earlier stage.
Many studies since 2016 have shown the utility of protein biomarkers evaluation of somatic mutations to identify the circulating cfDNA from tumour cells ctDNA differential fragmentation and methylation profiles of ctDNA, and presence of cancer-specific RNA species in the blood - with or without conventional radiological imaging techniques - to detect cancers before the emergence of distant metastases. Encouraged by these landmark studies, we seek to evaluate, coherently and comprehensively, many of these different next generation approaches for identification of cancer biomarkers and development of a non-invasive test for detection of oral cavity cancers (OCC and other oral potentially malignant disorders (OPMDs) to be introduced to the Indian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •An eligible patient must satisfy all of the following criteria for inclusion.
- •Must be 18 years or older.
- •Has been diagnosed with a cancer of the oral cavity by screening or clinical presentation.
- •Has been scheduled to undergo biopsy or surgical resection for a known or highly suspected malignancy in the oral cavity.
- •Shows no signs of metastasis.
- •Eligibility criteria for At-Risk Individuals with leukoplakia erythroplakia submucosal fibrosis oral lichen planus.
- •Must be between 18 and 65 years.
- •Has been diagnosed with suspected OPMDs by screening or clinical presentation.
- •Agrees to report any changes in medical condition.
- •Agrees to be followed up by telephonic conversation, once every six months, for up to two years Eligibility criteria for Apparent-Normal Individuals i.e. without any cancerous condition An Apparent Normal volunteer must satisfy all of the following criteria for inclusion.
- •Does not present any symptoms of a cancer in the oral cavity or elsewhere.
- •Does not have a serious medical history or a past oral surgery.
- •Does not have a history of cancer in the immediate family.
- •Agrees to be followed up by telephonic conversation once every six months for up to two years.
排除标准
- •Exclusion criteria for All cancer patients At risk and Apparent Normal Individuals The individual is not eligible to be included in the study if he or she Is unable to understand or willing to sign an institutional review board approved written informed consent document before any study specific procedures.
- •Is unwilling to comply with all study procedures.
- •Has any cancer other than OSCC or dysplasia in the oral cavity.
- •Has previously undergone an oral surgery in the past.
- •Has previously undergone a definitive local therapy or an extensive surgery.
- •Is currently undergoing or has received any chemotherapy radiotherapy or immunotherapy in the past.
- •Has fever or shows symptoms of a fever on the day of liquid biopsy Is a recipient of an organ transplant or allogenic bone marrow or stem cell transplant in the past Has undergone a blood transfusion in the last 30 days Has been treated with corticosteroids in the last 30 days Has a current or past pregnancy in the last 30 days.
- •Has a condition that, in the opinion of the clinician, would interfere with successful evaluation and interpretation of the results.
结局指标
主要结局
To assess the epigenetic and proteomic alterations in participants with OCC and identify potential biomarkers
时间窗: subjects Follow up will be done for every once in 6 months for 2 years for all the arm
次要结局
- Development of non-invasive diagnostic products for early detection of OCC and OPMD with high sensitivity and specificity(visit for every 6 months once for 2 years)
研究者
Dr H Thamizhchelvan
Sri Ramachandra Institute Of Higher Education and Research
