To test the disease free survival (DFS) prediction ability of the OncoDiscover diagnostic technology â?? a simple liquid biopsy blood test for cancer patients.
- Conditions
- Health Condition 1: null- Quasi-metastatic patients (stage II & stage III) suffering from the breast, colo-rectal, cervical, ovarian, esophageal / stomach and loco-regional (oral, larynx, tongue, head & neck etc.) cancers
- Registration Number
- CTRI/2018/04/012920
- Lead Sponsor
- Actorius Innovations and Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Quasi-metastatic patients (stage II & stage III) suffering from the breast, colo-rectal, cervical, ovarian, esophageal / stomach and loco-regional (oral, larynx, tongue, head & neck etc.) cancers would be considered for the aforementioned trial.
2. Males (lung, colorectal, esophageal, stomach, loco-regional) and/or females (Breast, ovarian, cervical, colorectal, esophageal, stomach, loco-regional).
3. Patients who are yet to receive the treatment.
4. Age > 18 years.
5. Patients who are well counselled about the trial and from who written informed consent obtained.
6. Confirmed diagnosis of Stage II or III cancer by oncologist.
7. Able to undergo blood collection after diagnosis and prior to surgery and initiation of the therapy,
8. Those patients, who would provide the blood sample after diagnosis, surgery and at the initiation, in the course of and at the end of the treatment.
1. Patients unable to understand the research protocol and/or provide informed consent.
2. Patients with known immunodeficiency, or pregnancy.
3. Participation in another cancer screening trial.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability of diagnostic technology for evaluation of CTC to predict PFS and DFS in patients suffering from breast, colorectal, esophageal / stomach, cervical, ovarian and loco-regional cancers. [Time Frame: 36 months].Timepoint: 36 months
- Secondary Outcome Measures
Name Time Method Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patients response as determined by CTC evaluation). [ Time Frame: 12 months] <br/ ><br> <br/ ><br>To correlate the data generated with TNM staging. [12 months]Timepoint: 12 months