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The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)
Sponsor study identifier
Secondary identifiers
NIH
observational
200
1 country
1
Study Start
September 30, 2019
Actual (reported)Primary Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies. New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients. Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA. As a reference, germ-line DNA will also be sampled, also from regular blood samples. The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced. The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2019
Actual (reported)July 19, 2019
Actual (reported)September 30, 2019
Actual (reported)December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Possibility of cellular and genomic sampling as part of the standardised care process
Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?
1 month
Cellular and genomic sample analyses
6 months
Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP). Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.
Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer. Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.
Patient stratification based on presence or absence of suspicious findings of cells and DNA
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.
Diagnostiskt Centrum, Södertälje Sjukhus
Södertälje, Stockholm County, 152 86, Sweden
Stenman E, Palmer K, Ryden S, Savblom C, Svensson I, Rose C, Ji J, Nilbert M, Sundquist J. Diagnostic spectrum and time intervals in Sweden's first diagnostic center for patients with nonspecific symptoms of cancer. Acta Oncol. 2019 Mar;58(3):296-305. doi: 10.1080/0284186X.2018.1537506. Epub 2019 Jan 11.
Castro, J., Ericsson C., Cashin P., Mahteme H. Preliminary Finding: Detection of Circulating Cancer Cells in Blood from a Patient with Peritoneal Carcinomatosis Treated with Cytoreductive Surgery and Intraperitoneal Chemotherapy. Surgery: Current Research 2(3), 2012. doi: 10.4172/2161-1076.1000113
Castro, J., Sanchez, L., Alvarez Bedoya, P.H., Nunez, M.T., Lu, M., Castro, T., Sharifi, H.R., Ericsson, C. Screening Circulating Tumor Cells as a Non-invasive Cancer Test in 1,585 Asymptomatic Adults (ICELLATE1) J Integr Oncol 7(3), 2018 DOI 10.4172/2329-6771.1000212
Peripheral blood samples
Charlotta Savblom, MD, PhD
Region Stockholm
Christer Ericsson, PhD
Karolinska Institutet
First Submitted
July 15, 2019
First Posted
July 19, 2019
Study Start
September 30, 2019
Actual (reported)Primary Completion
December 2020
Estimated (date passed)Contact the study team to confirm eligibility.
Castro J, Sanchez L, Nunez MT, Lu M, Castro T, Sharifi HR, Ericsson C. Screening Circulating Tumor Cells as a Noninvasive Cancer Test in 3388 Individuals from High-Risk Groups (ICELLATE2). Dis Markers. 2018 May 28;2018:4653109. doi: 10.1155/2018/4653109. eCollection 2018.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 4, 2019
Record last verified: 2019-10
There is no plan to make individual participant data (IPD) available to other researchers
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Source: ClinicalTrials.gov.
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