How endocrine tumors develop resistance to alkylating chemotherapy
Longitudinal Biomarker Study in Endocrine Neoplasms to Study Acquired Resistance to Alkylator Chemotherapy
This study will test whether patients with endocrine tumors who receive alkylating chemotherapy develop high tumor mutation rates and whether blood tests and imaging can detect those changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT07121998 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter study enrolling about 94 patients at Swedish endocrine cancer centers to track genetic changes after alkylating chemotherapy. Participants are divided into two groups: those about to start alkylating therapy and those with disease progression after prior alkylating treatment. The study collects tumor tissue biopsies, blood samples for circulating tumor DNA, and imaging to look for the emergence of high tumor mutational burden and mismatch repair–related mutations. Genomic sequencing will be used to quantify hypermutation and correlate tissue findings with non-invasive measures over time.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed endocrine neoplasms who are either about to start alkylating chemotherapy or have disease progression after prior alkylating treatment are ideal candidates.
Not a fit: Patients who have never received alkylating chemotherapy, who cannot safely undergo biopsy or blood draws, or who are pregnant are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the study could identify patients who develop therapy-induced hypermutation and enable non-invasive monitoring to guide treatment choices, including potential use of immunotherapy.
How similar studies have performed: Small prior studies, particularly in pancreatic neuroendocrine tumors, have reported chemotherapy-associated hypermutation in roughly 30% of cases, but broader confirmation in other endocrine neoplasms is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Age ≥18 years * Histopathology confirmed endocrine neoplasm * Treatment with alkylating chemotherapy: Arm A; about to start alkylating chemotherapy, or Arm B; at disease progression or recurrence with previous alkylating chemotherapy treatment. Exclusion Criteria: * If planned tissue biopsy: risk factors for biopsy-related complications accordingly to local investigator, including coagulation disorder * Long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk * Pregnancy
Where this trial is running
Uppsala
- Akademiska Sjukhuset — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Joakim Crona, MD PhD — Uppsala University Hospital
- Study coordinator: Lovisa Falkman, MD
- Email: lovisa.falkman@uu.se
- Phone: +46186110000
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.