All CancerNCT04249895
Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )
An observational study of All Cancer, run by Tata Medical Center at 1 site in India.
Trial summary
In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Cancer
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 31 Aug 2018to 28 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Patients undergoing radiotherapy in the dept of radiotherapy, Tata Medical Center.
Who may be able to join
- 1. Patients undergoing radiotherapy planned with volumetric imaging.
- -
Who cannot join
- Informed Consent not given
Trial locations and contacts
1 site in 1 country.
About this study
In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. It will support flexible query from the users with appropriate choice from a set of attributes and design of various query filters using a GUI. Over the proposed period of 18 months, images and records related to radiation oncology including pretreatment images of at least 500 patients would be annotated and archived in the data bank. The imaging modalities to be covered are X-RAY mammograms, SPECT, CT, CBCT, MR, PET-CT, Ultrasound, digital histopathology, etc. In this phase, this study will include data sets of five types of cancers namely, breast, head and neck, brain, cervix and lung cancer.
Investigator propose to demonstrate the application of this data set in cancer research. Investigator will work on serial PET-CT based radiomics of breast and cervix cancer patients to extract appropriate features and correlate them with clinico-pathological variants.
- Conditions
- All Cancer
- Keywords
- Carcinoma, Radiomics, Image Processing, Radiology, Molecular Biology, Data Analytics Center, Artificial Intelligence, Medical Physics, Big Data, Radiation Oncology
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | All patients are undergoing radiotherapy in Tata Medical Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete data safe.
Count of patients with complete radiological, pathological and demographic information in the CHAVI RO database.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start31 Aug 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249895
- Sponsor's protocol ID
- EC/GOVT/24/IRB23
- Status last verified
- Dec 2021
- First submitted
- 29 Jan 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )
- ClinicalTrials.gov ID
- NCT04249895
- Acronym / sponsor ID
- EC/GOVT/24/IRB23
- Conditions
- All Cancer
- Keywords
- Carcinoma, Radiomics, Image Processing, Radiology, Molecular Biology, Data Analytics Center, Artificial Intelligence, Medical Physics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tata Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 Jan 2020 (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.
In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. It will support flexible query from the users with appropriate choice from a set of attributes and design of various query filters using a GUI. Over the proposed period of 18 months, images and records related to radiation oncology including pretreatment images of at least 500 patients would be annotated and archived in the data bank. The imaging modalities to be covered are X-RAY mammograms, SPECT, CT, CBCT, MR, PET-CT, Ultrasound, digital histopathology, etc. In this phase, this study will include data sets of five types of cancers namely, breast, head and neck, brain, cervix and lung cancer.
Investigator propose to demonstrate the application of this data set in cancer research. Investigator will work on serial PET-CT based radiomics of breast and cervix cancer patients to extract appropriate features and correlate them with clinico-pathological variants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | –All patients are undergoing radiotherapy in Tata Medical Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients undergoing radiotherapy in the dept of radiotherapy, Tata Medical Center.
Key inclusion criteria (2 listed)
- 1. Patients undergoing radiotherapy planned with volumetric imaging.
- -
Key exclusion criteria (1 listed)
- Informed Consent not given
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
Number of patients with complete data safe.
Time frame: 18 months
Count of patients with complete radiological, pathological and demographic information in the CHAVI RO database.
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 17 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 All Cancer, run by Tata Medical Center 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 2 inclusion and 1 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 17 Dec 2021. 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?
Number of patients with complete data safe. (time frame: 18 months). 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 17 Dec 2021.