Leukemia, Lymphocytic, Chronic, B-CellNCT04290923
Determination of Blood Tumor Cells
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Abnormalities Cell Epithelial, run by University of Zurich at 1 site in Switzerland.
Trial summary
Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Abnormalities Cell Epithelial
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Criterion for the enrollment is the presence of an epithelial cell carcinoma or the presence of a non-solid tumor (i.e. lymphoma or leucemia)
Who may be able to join
- Epithelial cell cancer, advanced stage Non-solid tumors (lymphoma, leukemia)
Who cannot join
- Inability to understand the language of the center (German)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Blood Tumor Cells Using Magnetic Nanoparticles
Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood .
Read the 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).
- Keywords
- Epithelial Cell Adhesion Molecule, Magnetite Nanoparticles, Tumor cells
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Colorectal Cancer, Hereditary Nonpolyposis, Type 8
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CTC / lymphocytes removed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Oct 2017
- Primary completion26 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice H Beck Schimmer, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290923
- Sponsor's protocol ID
- 2016-01140
- Other IDs
- 2016
- Status last verified
- Jan 2023
- First submitted
- 27 Feb 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1056/NEJMoa040766.
PubMed 15317891Herrmann 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.
PubMed 21310738Herrmann IK, Schlegel A, Graf R, Schumacher CM, Senn N, Hasler M, Gschwind S, Hirt AM, Gunther 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.
PubMed 23900264
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Blood Tumor Cells Using Magnetic Nanoparticles
- ClinicalTrials.gov ID
- NCT04290923
- Acronym / sponsor ID
- 2016-01140
- Keywords
- Epithelial Cell Adhesion Molecule, Magnetite Nanoparticles, Tumor cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood .
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Criterion for the enrollment is the presence of an epithelial cell carcinoma or the presence of a non-solid tumor (i.e. lymphoma or leucemia)
Key inclusion criteria (1 listed)
- Epithelial cell cancer, advanced stage Non-solid tumors (lymphoma, leukemia)
Key exclusion criteria (1 listed)
- Inability to understand the language of the center (German)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of CTC / lymphocytes removed
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 15317891Cristofanilli 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. doi: 10.1056/NEJMoa040766.
- Background: PubMed 21310738Herrmann 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.
- Background: PubMed 23900264Herrmann IK, Schlegel A, Graf R, Schumacher CM, Senn N, Hasler M, Gschwind S, Hirt AM, Gunther 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice H Beck Schimmer, Prof principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell and Abnormalities Cell Epithelial, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CTC / lymphocytes removed (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.