Precision medicine treatment for difficult-to-treat solid tumors
MyCustom:A Framework for Prospective and Master Protocol Trial of Precise Drug Treatment for Refractory Solid Tumors
This study is testing whether personalized treatments based on the genetic makeup of hard-to-treat solid tumors can help patients who have run out of other options feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06030869 on ClinicalTrials.gov |
What this trial studies
The MyCustom study is a prospective observational trial focusing on precision medicine for patients with refractory solid tumors. It utilizes genetic biomarker-driven approaches, including Next Generation Sequencing (NGS), to analyze tumor samples and identify potential treatment options. Patients who have exhausted standard treatment options will have their genetic data reviewed by a Molecular Tumor Board (MTB) to prioritize drug matches for individualized treatment. The study aims to improve treatment outcomes by tailoring therapies based on genetic profiles.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced or metastatic solid cancers that have not responded to standard treatments.
Not a fit: Patients who are suitable for standard therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide personalized treatment options for patients with advanced solid tumors who have not responded to standard therapies.
How similar studies have performed: Other studies utilizing precision medicine and genetic profiling have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid cancer of any histological type, or an earlier diagnosis of cancer with a poor prognosis. Suffificient accessible tissue for molecular profifiling; 2. Patients receiving their last line of standard treatment or 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; 3. ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4)); 4. Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments; 5. Signed, written informed consent to participate. Exclusion Criteria: 1. Suitable for standard therapy; 2. Specific contraindications to exposure to the investigationalproducts; 3. 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; 4. Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer; 5. Pregnancy, lactation or inadequate contraception.
Where this trial is running
Tianjin, Tianjin
- Tianjin Medical University Second Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Haitao Wang, Ph.D — Tianjin Medical University Second Hospital
- Study coordinator: Haitao Wang, Ph.D
- Email: peterrock2000@126.com
- Phone: +86-022-88326610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.