RECRUITING

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.

Official Title

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

Quick Facts

Study Start:2023-11-02
Study Completion:2035-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06085833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged ≥ 18 years
  2. * Ability to understand and the willingness to sign a written informed consent.
  3. * Indication for breast biopsy for diagnostic purposes
  4. * ECOG performance status of 0 to 3.
  1. * Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

Contacts and Locations

Study Contact

Tobias Appenzeller
CONTACT
+41 79 454 48 24
tobias.appenzeller@artidis.com
Marko Loparic, MD,PhD
CONTACT
+41 61 633 29 93
Marko.Loparic@artidis.com

Principal Investigator

Alastair Thompson, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: ARTIDIS AG

  • Alastair Thompson, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2035-11

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2035-11

Terms related to this study

Keywords Provided by Researchers

  • Breast biopsy
  • breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer