Neoplasms, Unknown PrimaryNCT04025970
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP
An observational study of Neoplasms, Unknown Primary and Cancer, run by Christer Ericsson at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Neoplasms, Unknown Primary, Cancer
- What is being tested?
- Circulating tumor cell and circulating tumor DNA test
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2019to 31 Dec 2021
- 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 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.
Who may be able to join
- 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.
Who cannot join
- All patients who have been referred and consented are included.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Diagnostiskt Centrum, Södertälje Sjukhus
Södertälje, Stockholm County, 152 86
About this study
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)
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.
Read more
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.
- Conditions
- Neoplasms, Unknown Primary, Cancer
- Being tested
- Circulating tumor cell and circulating tumor DNA test
- Keywords
- Germ line DNA, gDNA, Circulating tumor cell, CTC, Circulating cell free DNA, cfDNA, ctDNA, Screening, Diagnostic, Predictive
- Medical subject headings
- Neoplasms, Unknown Primary, Neoplasms, Neoplastic Cells, Circulating, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cell and circulating tumor DNA testGenetic
Patient stratification based on presence or absence of suspicious findings of cells and DNA
| Study group | Role | What they receive |
|---|---|---|
| Cancer of Unknown Primary (CUP) | 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. Receives: Genetic: Circulating tumor cell and circulating tumor DNA test | |
| Suspected CANcer (SCAN) | 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. Receives: Genetic: Circulating tumor cell and circulating tumor DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 1 month
Secondary outcomes (1)
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?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start30 Sep 2019
- Primary completionDec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Unknown PrimaryStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christer Ericsson
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, iCellate Medical
- Responsible party
- Sponsor-investigator, Christer Ericsson, Region Stockholm
- Investigators
- Charlotta Savblom, MD, PhD, Study director, Region StockholmChrister Ericsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025970
- Sponsor's protocol ID
- 2019-01410
- Other IDs
- 2019
- Status last verified
- Oct 2019
- First submitted
- 15 Jul 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Publications
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.
PubMed 30632871Castro, 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
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.
PubMed 29997714
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04025970
- Acronym / sponsor ID
- 2019-01410
- Conditions
- Neoplasms, Unknown Primary, Cancer
- Keywords
- Germ line DNA, gDNA, Circulating tumor cell, CTC, Circulating cell free DNA, cfDNA, ctDNA, Screening, Diagnostic, Predictive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Christer EricssonOther government
- Collaborators
- Karolinska Institutet, iCellate Medical
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jul 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer of Unknown Primary (CUP) | – | Genetic: Circulating tumor cell and circulating tumor DNA testSubjects 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. |
| Suspected CANcer (SCAN) | – | Genetic: Circulating tumor cell and circulating tumor DNA testSubjects 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. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- All patients who have been referred and consented are included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor cell and circulating tumor DNA testPatient stratification based on presence or absence of suspicious findings of cells and DNA | Genetic | Cancer of Unknown Primary (CUP), Suspected CANcer (SCAN) |
Primary outcome
Possibility of cellular and genomic sampling as part of the standardised care process
Time frame: 1 month
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 secondary outcome
Cellular and genomic sample analyses
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 30632871Stenman 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.
- BackgroundCastro, 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
- BackgroundCastro, 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
- Background: PubMed 29997714Castro 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
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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.
Charlotta Savblom, MD, PhD study director
Region Stockholm
Christer Ericsson, PhD principal investigator
Karolinska Institutet
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 Neoplasms, Unknown Primary and Cancer, run by Christer Ericsson at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 4 Oct 2019. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roland Soderholm, MD (08-550 24493, roland.soderholm@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Possibility of cellular and genomic sampling as part of the standardised care process (time frame: 1 month). 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 NCT04025970, which also lists 4 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 4 Oct 2019.