forecasting capacity of Circulating Free DNA to assess treatment results in Patients with Oral Cancer
- Conditions
- Health Condition 1: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 2: null- patients with oral cavity cancer
- Registration Number
- CTRI/2019/03/018136
- Lead Sponsor
- RMLIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Treatment naive cases with early and
locally advanced cancer of oral cavity, confirmed by biopsy ( histopathology will be gold standard for diagnosis).
2. Potential candidate for surgery
3. Performance status: ECOG 0-2
4. Patient consent to be part of study.
1. Patients having a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin.
2. Metastatic cancer of oral cavity.
•Performance status: ECOG: >=3.
•Presence of second malignancy.
•Patients unwilling to take active treatment or to join the study.
•A serious co-existing medical condition likely to interfere with lab results including a potentially serious infection.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proposed study is to assess the level of cfDNA in peripheral blood of early and locally advanced cases of oral cavity cancers initially before treatmentTimepoint: 2 years from the start of the study
- Secondary Outcome Measures
Name Time Method To evaluate cfDNA as response assessment tool in the patients receiving induction chemotherapy <br/ ><br>To correlate cfDNA level with clinical & histo-pathological prognostic parameters. <br/ ><br>To correlate cfDNA with subsequent recurrence in a 18 months. <br/ ><br>Timepoint: 1.5 years