Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

Cancer Clinical Trial

Official title:

The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025970
• Other study ID #: 2019-01410
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Stockholm County Council, Sweden
• Contact: Roland Soderholm, MD
• Phone: 08-550 24493
• Email: roland.soderholm[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 125 Years

Eligibility

Inclusion Criteria:

• 200 patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study.

Exclusion Criteria:

• All patients who have been referred and consented are included.

Related Conditions & MeSH terms

• Cancer
• Neoplasms, Unknown Primary

Intervention

Genetic:
• Circulating tumor cell and circulating tumor DNA test
Patient stratification based on presence or absence of suspicious findings of cells and DNA

Locations

Country	Name	City	State
Sweden	Diagnostiskt Centrum, Södertälje Sjukhus	Södertälje	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Christer Ericsson	iCellate Medical, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Castro J, Sanchez L, Nuñez 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. — View Citation

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

Stenman E, Palmér K, Rydén S, Sävblom 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Cellular and genomic sample analyses	Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease?	6 months

External Links

•   iCellate Medical offers services in liquid biopsy, to detect, isolate and analyze circulating tumor cells (CTCs), circulating tumor DNA and germ-line DNA, from normal blood samples.
•   The regional cancer centers of the public healthcare system will work to strengthen clinical cancer research in the region and in the country so that scientific advances will rapidly benefit cancer patients.