Solid TumorNCT06456216
Performance Evaluation of Diagnostic Accuracy of PanTum Detect Test for Detection of Solid Tumours in Known Cancer Population and in Cancer Free Population.
An observational study of Solid Tumor, run by Max Healthcare Insititute Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 21 Feb 2022to 20 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- written informed consent
- sick population with hiostopathology proven diagnosis
- age 30-75 years
- newly diagnosed case of solid tumor.
Who cannot join
- history of past surgery within 8 weeks.
- history of any chemotherapy, vaccination etc
Trial locations and contacts
1 site in 1 country.
India1 site
Max Super Speciality Hospital, A Unit of Devki Devi Foundation
New Delhi, 110017
About this study
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.
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.
Read the 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
- Conditions
- Solid Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start21 Feb 2022
- Primary completion14 Nov 2022
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harit Chaturvedi, MCH, Principal investigator, Max Super Speciality Hospital, Saket
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456216
- Sponsor's protocol ID
- MOI-PAN-2022
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06456216
- Acronym / sponsor ID
- MOI-PAN-2022
- Conditions
- Solid Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- written informed consent
- sick population with hiostopathology proven diagnosis
- age 30-75 years
- newly diagnosed case of solid tumor.
Key exclusion criteria (2 listed)
- history of past surgery within 8 weeks.
- history of any chemotherapy, vaccination etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harit Chaturvedi, MCH principal investigator
Max Super Speciality Hospital, Saket
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by Max Healthcare Insititute Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.