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

Solid Tumor Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456216
• Other study ID #: MOI-PAN-2022
• Status: Completed
• Start date: February 21, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: June 2024
• Source: Max Healthcare Insititute Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 20, 2023
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Locations

Country	Name	City	State
India	Max Super Speciality Hospital, A Unit of Devki Devi Foundation	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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