Performance Evaluation of Diagnostic Accuracy of PanTum Detect Test for Detection of Solid Tumours in Known Cancer Population and in Cancer Free Population.

NCT06456216 | Completed DMC

• 1 other identifier: MOI-PAN-2022
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population.

  PanTum Detect is a simple blood test that can detect presence of solid tumors using two important tumor biomarkers - Apo 10 and TKTL-1. Most tumors develop slowly and gradually. From the first tumor cell, to the identification of the tumor itself, there can be a timespan of many years. The turning point where a locally growing tumor develops into an invasive, metastasizing cancer is paramount for curability. It is the objective of PanTum Detect to detect a tumor in time before this critical turning point. Such locally growing tumors can often easily be removed by surgery or treated successfully.

  1 YEAR

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

this evaluation study will be done in 3 groups of 60 subjects each using 3 differents lots of pantum detect test kit. each group will have an equal population of patients with primary tomur disease( the sick population) and healthy populations.

You may qualify if:

• written informed consent
• sick population with hiostopathology proven diagnosis
• age 30-75 years
• newly diagnosed case of solid tumor.

You may not qualify if:

• history of past surgery within 8 weeks.
• history of any chemotherapy, vaccination etc

Sponsors & Collaborators

• Max Healthcare Insititute Limited: lead

Study Sites (1)

Max Super Speciality Hospital, A Unit of Devki Devi Foundation

New Delhi, 110017, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

PanTum Detect uses the biomarkers Apo10 and TKTL1.

Study Officials

• Harit Chaturvedi, MCH

  Max Super Speciality Hospital, Saket

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 13, 2024
• Study Start: February 21, 2022
• Primary Completion: November 14, 2022
• Study Completion: October 20, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

IN (1)