Colorectal CancerNCT03640572
Disseminated Tumour Cells (DTC) in Left Sided Colorectal Cancer (LSCC).
An observational study of Colorectal Cancer and Bone Marrow Tumor Cell Infiltration, run by Jagiellonian University at 1 site in Poland.
Trial summary
Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Bone Marrow Tumor Cell Infiltration
- What is being tested?
- Bone marrow analysis to identify disseminated tumour cells
- How many people
- 91 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2007to 30 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with left-sided colorectal cancer operated on in one tertiary centre.
Who may be able to join
- age > 18 years
- histologically proven left-sided colorectal cancer
- signed informed consent
Who cannot join
- synchronous right sided colon cancer
- history of other neoplasm
- inability to understand and sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Disseminated Tumour Cells in Bone Marrow in Patients With Left-sided Colorectal Cancer.
Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. However there is no sufficient evidence that disseminated tumour cells (DTC) in the bone marrow of the colorectal cancer patients influence the prognosis. There is the evidence that right-sided and left- sided cancers may have different biology and different prognosis. Therefore in this study the investigators concentrated on the left colon and rectum locations with the locally advanced cancer being the main area of interest.
The aim of this study was to analyse the relation of DTC with the tumor characteristics, cancer progression and survival in left sided colorectal cancer.
Read the detailed description
A group of 91 colorectal patients treated in a single institution was involved into the study. Only the patients with tumors located in the rectum or left side colon were included. The term left colon was defined as the left 1/3 of transverse colon and all the colon parts distally from this point. None of the colon cancer patients received preoperative chemotherapy, while 5 of the rectal cancer patients received preoperative radiotherapy and two preoperative radiochemotherapy. There were 42 women and 49 men, the mean age 64,7 (SD - standard deviation 10,2). The bone marrow biopsy was performed on the day of surgery after the induction of general anesthesia from posterior superior iliac spine. The 5ml sample of the bone marrow was collected to plastic tubes containing EthyleneDiamineTetraacetic (EDTA). Patients received postoperative chemotherapy if indicated, regardless of their DTC status. All the patients were followed up at least for 5 years or until death.
The incidence of DTC was not related to the depth of infiltration (T feature) being similar in T1-2 and T4 patients. There was no statistically significant difference between the incidence of DTC in N- and N+ patients. The 5 years survival rate for the DTC patients was 59,5% while for the DTC negative patients was 53%.
- Being tested
- Bone marrow analysis to identify disseminated tumour cells
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow analysis to identify disseminated tumour cellsDiagnostic test
Pelleted cells from bone marrow samples were incubated with an excessive amount of lysing solution for 10 min, repeated 3-4 times to remove erythrocytes. The slides were dried, fixed with a mixture of ethanol and acetone (1 : 1 v v-1), and then stained for 30 min with A45-B/B3 monoclonal antibodies (5 μg ml-1) (Micromet GmbH, Germany), which recognise common epitopes of cytokeratins (CK) including CK 8, 18 and 19.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow DTC | Patients with left-sided colorectal cancer and disseminated tumour cells in the bone marrow Receives: Diagnostic Test: Bone marrow analysis to identify disseminated tumour cells | |
| No bone marrow DTC | Patients with left-sided colorectal cancer and no disseminated tumour cells in the bone marrow Receives: Diagnostic Test: Bone marrow analysis to identify disseminated tumour cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS in patients with and without DTC in bone marrow
Measured: 5 years
Secondary outcomes (2)
Local recurrence rate
Local recurrence in patients with and without DTC in bone marrow
Measured: 5 years
Systemic recurrence
Systemic recurrence in patients with and without DTC in bone marrow
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jun 2007
- Primary completion31 Dec 2012
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, MD, Ph D, Jagiellonian University
- Investigators
- Antoni Szczapanik, Assoc. Prof., Study chair, Jagiellonian diversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640572
- Sponsor's protocol ID
- DCT LSCC
- Status last verified
- Feb 2019
- First submitted
- 17 Aug 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Disseminated Tumour Cells in Bone Marrow in Patients With Left-sided Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT03640572
- Acronym / sponsor ID
- DCT LSCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 21 Aug 2018 (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.
Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. However there is no sufficient evidence that disseminated tumour cells (DTC) in the bone marrow of the colorectal cancer patients influence the prognosis. There is the evidence that right-sided and left- sided cancers may have different biology and different prognosis. Therefore in this study the investigators concentrated on the left colon and rectum locations with the locally advanced cancer being the main area of interest.
The aim of this study was to analyse the relation of DTC with the tumor characteristics, cancer progression and survival in left sided colorectal cancer.
Detailed description
A group of 91 colorectal patients treated in a single institution was involved into the study. Only the patients with tumors located in the rectum or left side colon were included. The term left colon was defined as the left 1/3 of transverse colon and all the colon parts distally from this point. None of the colon cancer patients received preoperative chemotherapy, while 5 of the rectal cancer patients received preoperative radiotherapy and two preoperative radiochemotherapy. There were 42 women and 49 men, the mean age 64,7 (SD - standard deviation 10,2). The bone marrow biopsy was performed on the day of surgery after the induction of general anesthesia from posterior superior iliac spine. The 5ml sample of the bone marrow was collected to plastic tubes containing EthyleneDiamineTetraacetic (EDTA). Patients received postoperative chemotherapy if indicated, regardless of their DTC status. All the patients were followed up at least for 5 years or until death.
The incidence of DTC was not related to the depth of infiltration (T feature) being similar in T1-2 and T4 patients. There was no statistically significant difference between the incidence of DTC in N- and N+ patients. The 5 years survival rate for the DTC patients was 59,5% while for the DTC negative patients was 53%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow DTC | – | Diagnostic Test: Bone marrow analysis to identify disseminated tumour cellsPatients with left-sided colorectal cancer and disseminated tumour cells in the bone marrow |
| No bone marrow DTC | – | Diagnostic Test: Bone marrow analysis to identify disseminated tumour cellsPatients with left-sided colorectal cancer and no disseminated tumour cells in the bone marrow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left-sided colorectal cancer operated on in one tertiary centre.
Key inclusion criteria (3 listed)
- age > 18 years
- histologically proven left-sided colorectal cancer
- signed informed consent
Key exclusion criteria (3 listed)
- synchronous right sided colon cancer
- history of other neoplasm
- inability to understand and sign informed consent
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 |
|---|---|---|
| Bone marrow analysis to identify disseminated tumour cellsPelleted cells from bone marrow samples were incubated with an excessive amount of lysing solution for 10 min, repeated 3-4 times to remove erythrocytes. The slides were dried, fixed with a mixture of ethanol and acetone (1 : 1 v v-1), and then stained for 30 min with A45-B/B3 monoclonal antibodies (5 μg ml-1) (Micromet GmbH, Germany), which recognise common epitopes of cytokeratins (CK) including CK 8, 18 and 19. | Diagnostic test | Bone Marrow DTC, No bone marrow DTC |
Primary outcome
Overall survival (OS)
Time frame: 5 years
OS in patients with and without DTC in bone marrow
2 secondary outcomes
Local recurrence rate
Time frame: 5 years
Systemic recurrence
Time frame: 5 years
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 27 Feb 2019.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Antoni Szczapanik, Assoc. Prof. study chair
Jagiellonian diversity
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 Colorectal Cancer and Bone Marrow Tumor Cell Infiltration, run by Jagiellonian University at 1 site in Poland.
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 3 inclusion and 3 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 27 Feb 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 Poland. 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?
Overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.