CompletedNot Applicable

The Registry of Oncology Outcomes Associated With Testing and Treatment

United States167 participantsStarted 2021-05-05

Plain-language summary

This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient or representative provides written informed consent * Patient is diagnosed with advanced malignancy * Patient is willing to be treated for this malignancy according to a plan determine by them and their physician * patient will be willing to have regular follow up visits as part of their standard of care Exclusion Criteria: * patient is not a candidate or does not desire any treatment for their disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best overall response (BOR) - 1st line of therapy

Timeframe: 1st line of therapy, on average less than 1 year

Best overall response (BOR) - 2nd line of therapy

Timeframe: 2nd line of therapy, on average less than 1 year

Best overall response (BOR) - 3rd line of therapy

Timeframe: 3rd line of therapy, on average less than 1 year

Best overall response (BOR) - 4th line of therapy

Timeframe: 4th line of therapy, on average less than 1 year

Best overall response (BOR) - 5th line of therapy

Timeframe: 5th line of therapy, on average less than 1 year

Progression-free survival (PFS) - 1st line of therapy

Timeframe: 1st line of therapy, on average less than 1 year

Progression-free survival (PFS) - 2nd line of therapy

Timeframe: 2nd line of therapy, on average less than 1 year

Trial details

NCT IDNCT04028479

SponsorTaproot Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Adenocarcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Best overall response (BOR) - 1st line of therapy

Timeframe: 1st line of therapy, on average less than 1 year

Best overall response (BOR) - 2nd line of therapy

Timeframe: 2nd line of therapy, on average less than 1 year

Best overall response (BOR) - 3rd line of therapy

Timeframe: 3rd line of therapy, on average less than 1 year

Best overall response (BOR) - 4th line of therapy

Timeframe: 4th line of therapy, on average less than 1 year

Best overall response (BOR) - 5th line of therapy

Timeframe: 5th line of therapy, on average less than 1 year

Progression-free survival (PFS) - 1st line of therapy

Timeframe: 1st line of therapy, on average less than 1 year

Progression-free survival (PFS) - 2nd line of therapy

Timeframe: 2nd line of therapy, on average less than 1 year