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

June 5, 2024 updated by: Max Healthcare Insititute Limited

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.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110017
        • Max Super Speciality Hospital, A Unit of Devki Devi Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 YEAR
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Healthcare Insititute Limited

Investigators

  • Principal Investigator: Harit Chaturvedi, MCH, Max Super Speciality Hospital, Saket

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOI-PAN-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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