How endocrine tumors develop resistance to alkylating chemotherapy
Official title: Longitudinal Biomarker Study in Endocrine Neoplasms to Study Acquired Resistance to Alkylator Chemotherapy
Run by Uppsala University · NCT07121998 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Uppsala) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2030 |
| Registry record updated | August 14, 2025 |
| Trial ID | NCT07121998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
External validation of the TB-NET score in advanced well‑differentiated neuroendocrine tumors
This study tests whether the TB-NET score can predict progression-free survival in adults with advanced well-differentiated gastroenteropancreatic neuroendocrine tumors or lung carcinoids who have received systemic therapy.
-
Ultralow-dose PET imaging of somatostatin receptor 2 (SSTR2) uptake
This study will test whether an ultralow-dose 68Ga-Dotatate PET scan on a high-sensitivity scanner can detect SSTR2 uptake in adults with and without neuroendocrine tumors.
-
Quality of life after surgery for neuroendocrine tumors
This study looks at how surgery for neuroendocrine tumors affects the quality of life for patients to help improve their care after the operation.
-
Removal of the primary small-intestine neuroendocrine tumor versus systemic therapy alone
This project tries to see if removing the main small-intestine neuroendocrine tumor helps people with incurable metastatic disease live longer or avoid future problems, compared with treating them with systemic therapy alone.
-
Using advanced imaging to detect small bowel neuroendocrine tumors
This study is testing a new imaging method to see if it can better find small bowel neuroendocrine tumors in patients, helping doctors decide on the best treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.