Determination of Blood Tumor Cells

• Sponsor: University of Zurich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04290923
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 65.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood .

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Chronic, B-Cell; Abnormalities Cell Epithelial

Detailed Description

Magnetic nanoparticles, coated with epithelial cell adhesion molecule (EpCAM)-antibodies are designed to interact with epithelial tumor cells. Aim of this study is to see if circulating tumor cells (EpCAM as marker)can be removed out of the blood with the help of these particles. Patients suffering from prostate, colon, lung or pancreatic cancer will be asked to test their blood.

Similarly, magnetic nanoparticles will be coated with antibodies, directed against non-solid tumors in the blood such as lymphoma or leukemia (CD52 as marker).

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Determination of Blood Tumor Cells Using Magnetic Nanoparticles
• Actual Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 30, 2023

Outcome Measures

Primary Outcome Measures

1. Number of CTC / lymphocytes removed [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

Epithelial cell cancer, advanced stage Non-solid tumors (lymphoma, leukemia)

Exclusion Criteria:

Inability to understand the language of the center (German)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Beatrice H Beck Schimmer, Prof, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91.
• Herrmann IK, Bernabei RE, Urner M, Grass RN, Beck-Schimmer B, Stark WJ. Device for continuous extracorporeal blood purification using target-specific metal nanomagnets. Nephrol Dial Transplant. 2011 Sep;26(9):2948-54. doi: 10.1093/ndt/gfq846. Epub 2011 Feb 10.
• Herrmann IK, Schlegel A, Graf R, Schumacher CM, Senn N, Hasler M, Gschwind S, Hirt AM, Günther D, Clavien PA, Stark WJ, Beck-Schimmer B. Nanomagnet-based removal of lead and digoxin from living rats. Nanoscale. 2013 Sep 21;5(18):8718-23. doi: 10.1039/c3nr02468g.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04290923
• Other Study ID Numbers: 2016-01140
• First Posted: Mar 2, 2020
• Last Update Posted: Oct 6, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: Epithelial Cell Adhesion Molecule; Magnetite Nanoparticles; Tumor cells
• Additional relevant MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Oct 6, 2021