Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Eva… (NCT06956248) | Clinical Trial Compass
RecruitingNot Applicable
Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
Singapore50 participantsStarted 2024-09-12
Plain-language summary
This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board.
1. To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations.
\- Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations.
2. To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study.
* Through standard safety laboratory investigations (FBC, U/E/Cr, LFT)
* Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months.
Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development
Who can participate
Age range
21 Years – 99 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
. Is equal to or greater than 21 years of age;
. Histologic or cytologic confirmed advanced solid tumours;
. Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
. Ability to understand and the willingness to provide written informed consent.
Exclusion criteria
. Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
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.
. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol.