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Study of Acquired Resistance to Alkylator Chemotherapy in Endocrine Neoplasms

Recruitingn/aAges 18 Years - anyAllUppsala University
NCT07121998 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

It has been showed that alkylating chemotherapy, particularly the widely used agent temozolomide, may cause high tumor mutational burden (TMB) in certain tumors by causing inactivating mutations in the DNA mismatch repair (MMR) system. This can cause therapy resistance and tumor progression but may also predict response for immunotherapy. Hypermutation is very uncommon in neuroendocrine tumors. However, small studies indicate that around 30% of pancreatic tumors develop high TMB after alkylating chemotherapy. The aim of this study is therefore to study the occurrence and frequency of DNA hypermutation after alkylating chemotherapy in endocrine neoplasms and to investigate non-invasive methods that may capture the development of hypermutation (imaging, ctDNA etc.). This is a prospective multicenter study. 94 patients from Swedish endocrine cancer centers in Uppsala, Stockholm, Göteborg a

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📋 Eligibility rules (as published)
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
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What it tests

  • Core needle biopsy
  • Phlebotomy
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Where

1 site
Akademiska Sjukhuset
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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