Colonic NeoplasmsNCT05727007
CT and MRI in Preoperative Colon Cancer Staging
A study testing MRI in colon cancer and CT in colon cancer in people with Colonic Neoplasms, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- MRI in colon cancer and CT in colon cancer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 23 Jan 2019to 15 May 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colonic adenocarcinoma
- Patient 18 to 90 years old
- Abscence of comorbidities that may affect treatment
- Signed informed consent of the patient
Who cannot join
- Inability to receive or contraindication for intravenous contrast
- Renal impairment
- Previous allergies to intravenous contrasts
- Incompatible implants with magnetic resonance imaging
- Claustrophobia
- Active sepsis or systemic infection
Show all 9Show fewer
- Untreated physical and mental disability
- Lack of compliance with the protocol process
- Non-granting of signed informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Surgery, University Hospital of Larissa
Larissa, 41110
About this study
Official title: Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer
The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection.
Read the detailed description
Over the last years a significant improvement in the treatment of patients with colon cancer has been reported. This has been attributed to the improvement of the staging techniques, as well as the optimization of the surgical management. However, the current five-year survival rates of colon cancer patients in European countries ranges from 32% to 64%. This variation could be due to treatment discrepancies and the lack of adherence to the international guidelines.
Surgical treatment of colon cancer includes the radical resection of the tumour (colectomy). Following resection, the specimen is histopathologically examined, the disease is staged and further treatment is determined. Neoadjuvant treatment (radiotherapy or/and chemotherapy) for colon cancer has not been yet approved, unlike rectal cancer, where neoadjuvant treatment is recommended for specific disease stages.
Preoperative staging of colon cancer aims to identify those patients with remote metastatic disease, who will, more likely, not benefit from upward surgery. Recent developments in colon cancer management, demanding more precise local disease staging, to identify those patients who will likely benefit from neoadjuvant chemotherapy, are still at a clinical trial stage.
Preoperative treatment depends on the disease stage, which is defined by the tumour's invasion in the colonic wall, the dissemination in nearby organs or lymph nodes, and the presence of distal metastases. The stage is first evaluated radiologically and then confirmed via histopathological examination of the specimen. Imaging is an already approved tool for the staging of colonic cancer, while in some studies the combination of different imaging methods has been reported to improve the initial evaluation.
Over the last years, evaluation of the circumferential resection margin (CRM) is also recommended in the preoperative staging of patients with colon cancer. This assessment is particularly important for tumours located at the cecum, right, or left colon, since these areas lack of mobile mesocolon and therefore it is possible to infiltrate the retroperitoneal resection margin.
Nevertheless, the retroperitoneal invasion of these tumours has not been evaluated adequately as a preoperative marker for both local recurrence and for the selection of patients who may benefit from neoadjuvant treatment. In various studies the percentage of retroperitoneal resection margin's infiltration was between 7-10% for cecum and right colon adenocarcinomas, while its presence was identified as a risk factor for local recurrence. The retroperitoneal surface infiltration was preoperatively evaluated with the combination of imaging methods and the findings were postoperatively compared with the histopathological features of the specimen.
A more precise, imaging based, preoperative staging, could lead to a more targeted neoadjuvant treatment for patients with advanced disease, with the introduction of chemo- and/or radiotherapy. This approach could result to the downstaging of the tumour, with better short and long term oncological results.
- Conditions
- Colonic Neoplasms
- Being tested
- MRI in colon cancer, CT in colon cancer
- Keywords
- colon, cancer, computed tomography, magnetic resonance, diffusion, preoperative, staging
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI in colon cancerDiagnostic test
The MRI protocol will include the following imaging series: T1 and T2 in axial and coronal plane before the administration of intravenous contrast, diffuse weight imaging in axial plane and T1 after the administration of intravenous contrast
CT in colon cancerDiagnostic test
The CT scan protocol will include the following: per os and intravenous administration of contrast, axial slices of 0.3mm thickness and reconstruction per 1mm, multi-planar reformation and three-dimensional volume rendering
| Study group | Role | What they receive |
|---|---|---|
| MRI in colon cancer | Experimental | All prospectively included patients with colon cancer will be preoperatively submitted to MRI for staging. The evaluation of the diagnostic accuracy will be based on the cross-examination with the CT scan and the pathology results Receives: Diagnostic Test: MRI in colon cancer; Diagnostic Test: CT in colon cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in T stage
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Measured: 1 month postoperatively
Secondary outcomes (3)
Diagnostic accuracy in N stage
Evaluation of diagnostic accuracy in the presence of local or distant metastatic lymph nodes. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Measured: 1 month postoperatively
Diagnostic accuracy in the retroperitoneal resection margin
Evaluation of diagnostic accuracy in the retroperitoneal resection margin. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Measured: 1 month postoperatively
Diagnostic accuracy in peritoneal or nearby organ infiltration
Evaluation of diagnostic accuracy in the peritoneal or nearby organ infiltration. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start23 Jan 2019
- Primary completion15 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will employ a prospective design
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Effrosyni Bompou, Larissa University Hospital
- Investigators
- George Tzovaras, Prof, Study chair, University Hospital of LarissaEffrosyni Bompou, MSc, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727007
- Sponsor's protocol ID
- CTMR
- Status last verified
- Oct 2023
- First submitted
- 25 Jan 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual patient data
Publications
Xynos E, Gouvas N, Triantopoulou C, Tekkis P, Vini L, Tzardi M, Boukovinas I, Androulakis N, Athanasiadis A, Christodoulou C, Chrysou E, Dervenis C, Emmanouilidis C, Georgiou P, Katopodi O, Kountourakis P, Makatsoris T, Papakostas P, Papamichael D, Pentheroudakis G, Pilpilidis I, Sgouros J, Vassiliou V, Xynogalos S, Ziras N, Karachaliou N, Zoras O, Agalianos C, Souglakos J; [the Executive Team on behalf of the Hellenic Society of Medical Oncology (HeSMO)]. Clinical practice guidelines for the surgical management of colon cancer: a consensus statement of the Hellenic and Cypriot Colorectal Cancer Study Group by the HeSMO. Ann Gastroenterol. 2016 Jan-Mar;29(1):3-17.
PubMed 26752945Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96. doi: 10.1093/jnci/93.8.583.
PubMed 11309435Jhaveri KS, Hosseini-Nik H. MRI of Rectal Cancer: An Overview and Update on Recent Advances. AJR Am J Roentgenol. 2015 Jul;205(1):W42-55. doi: 10.2214/AJR.14.14201.
PubMed 26102418Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
PubMed 23017669Nerad E, Lambregts DM, Kersten EL, Maas M, Bakers FC, van den Bosch HC, Grabsch HI, Beets-Tan RG, Lahaye MJ. MRI for Local Staging of Colon Cancer: Can MRI Become the Optimal Staging Modality for Patients With Colon Cancer? Dis Colon Rectum. 2017 Apr;60(4):385-392. doi: 10.1097/DCR.0000000000000794.
PubMed 28267005Jacobs MA, Macura KJ, Zaheer A, Antonarakis ES, Stearns V, Wolff AC, Feiweier T, Kamel IR, Wahl RL, Pan L. Multiparametric Whole-body MRI with Diffusion-weighted Imaging and ADC Mapping for the Identification of Visceral and Osseous Metastases From Solid Tumors. Acad Radiol. 2018 Nov;25(11):1405-1414. doi: 10.1016/j.acra.2018.02.010. Epub 2018 Apr 4.
PubMed 29627288Kijima S, Sasaki T, Nagata K, Utano K, Lefor AT, Sugimoto H. Preoperative evaluation of colorectal cancer using CT colonography, MRI, and PET/CT. World J Gastroenterol. 2014 Dec 7;20(45):16964-75. doi: 10.3748/wjg.v20.i45.16964.
PubMed 25493009Antoch G, Vogt FM, Freudenberg LS, Nazaradeh F, Goehde SC, Barkhausen J, Dahmen G, Bockisch A, Debatin JF, Ruehm SG. Whole-body dual-modality PET/CT and whole-body MRI for tumor staging in oncology. JAMA. 2003 Dec 24;290(24):3199-206. doi: 10.1001/jama.290.24.3199.
PubMed 14693872Hunter C, Blake H, Jeyadevan N, Abulafi M, Swift I, Toomey P, Brown G. Local staging and assessment of colon cancer with 1.5-T magnetic resonance imaging. Br J Radiol. 2016 Aug;89(1064):20160257. doi: 10.1259/bjr.20160257. Epub 2016 May 26.
PubMed 27226219Ellebaek SB, Fristrup CW, Mortensen MB. Intraoperative Ultrasound as a Screening Modality for the Detection of Liver Metastases during Resection of Primary Colorectal Cancer - A Systematic Review. Ultrasound Int Open. 2017 Apr;3(2):E60-E68. doi: 10.1055/s-0043-100503. Epub 2017 Jun 7.
PubMed 28597000Elibol FD, Obuz F, Sokmen S, Terzi C, Canda AE, Sagol O, Sarioglu S. The role of multidetector CT in local staging and evaluation of retroperitoneal surgical margin involvement in colon cancer. Diagn Interv Radiol. 2016 Jan-Feb;22(1):5-12. doi: 10.5152/dir.2015.15089.
PubMed 26611110Bateman AC, Carr NJ, Warren BF. The retroperitoneal surface in distal caecal and proximal ascending colon carcinoma: the Cinderella surgical margin? J Clin Pathol. 2005 Apr;58(4):426-8. doi: 10.1136/jcp.2004.019802.
PubMed 15790712Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.
PubMed 24582925Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
PubMed 6751457West NP, Hohenberger W, Weber K, Perrakis A, Finan PJ, Quirke P. Complete mesocolic excision with central vascular ligation produces an oncologically superior specimen compared with standard surgery for carcinoma of the colon. J Clin Oncol. 2010 Jan 10;28(2):272-8. doi: 10.1200/JCO.2009.24.1448. Epub 2009 Nov 30.
PubMed 19949013
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer
- ClinicalTrials.gov ID
- NCT05727007
- Acronym / sponsor ID
- CTMR
- Conditions
- Colonic Neoplasms
- Keywords
- colon, cancer, computed tomography, magnetic resonance, diffusion, preoperative, staging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Feb 2023 (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.
The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection.
Detailed description
Over the last years a significant improvement in the treatment of patients with colon cancer has been reported. This has been attributed to the improvement of the staging techniques, as well as the optimization of the surgical management. However, the current five-year survival rates of colon cancer patients in European countries ranges from 32% to 64%. This variation could be due to treatment discrepancies and the lack of adherence to the international guidelines.
Surgical treatment of colon cancer includes the radical resection of the tumour (colectomy). Following resection, the specimen is histopathologically examined, the disease is staged and further treatment is determined. Neoadjuvant treatment (radiotherapy or/and chemotherapy) for colon cancer has not been yet approved, unlike rectal cancer, where neoadjuvant treatment is recommended for specific disease stages.
Preoperative staging of colon cancer aims to identify those patients with remote metastatic disease, who will, more likely, not benefit from upward surgery. Recent developments in colon cancer management, demanding more precise local disease staging, to identify those patients who will likely benefit from neoadjuvant chemotherapy, are still at a clinical trial stage.
Preoperative treatment depends on the disease stage, which is defined by the tumour's invasion in the colonic wall, the dissemination in nearby organs or lymph nodes, and the presence of distal metastases. The stage is first evaluated radiologically and then confirmed via histopathological examination of the specimen. Imaging is an already approved tool for the staging of colonic cancer, while in some studies the combination of different imaging methods has been reported to improve the initial evaluation.
Over the last years, evaluation of the circumferential resection margin (CRM) is also recommended in the preoperative staging of patients with colon cancer. This assessment is particularly important for tumours located at the cecum, right, or left colon, since these areas lack of mobile mesocolon and therefore it is possible to infiltrate the retroperitoneal resection margin.
Nevertheless, the retroperitoneal invasion of these tumours has not been evaluated adequately as a preoperative marker for both local recurrence and for the selection of patients who may benefit from neoadjuvant treatment. In various studies the percentage of retroperitoneal resection margin's infiltration was between 7-10% for cecum and right colon adenocarcinomas, while its presence was identified as a risk factor for local recurrence. The retroperitoneal surface infiltration was preoperatively evaluated with the combination of imaging methods and the findings were postoperatively compared with the histopathological features of the specimen.
A more precise, imaging based, preoperative staging, could lead to a more targeted neoadjuvant treatment for patients with advanced disease, with the introduction of chemo- and/or radiotherapy. This approach could result to the downstaging of the tumour, with better short and long term oncological results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will employ a prospective design
| Arm | Type | Receives |
|---|---|---|
| MRI in colon cancer | Experimental | Diagnostic Test: MRI in colon cancer, Diagnostic Test: CT in colon cancerAll prospectively included patients with colon cancer will be preoperatively submitted to MRI for staging. The evaluation of the diagnostic accuracy will be based on the cross-examination with the CT scan and the pathology results |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed colonic adenocarcinoma
- Patient 18 to 90 years old
- Abscence of comorbidities that may affect treatment
- Signed informed consent of the patient
Key exclusion criteria (9 listed)
- Inability to receive or contraindication for intravenous contrast
- Renal impairment
- Previous allergies to intravenous contrasts
- Incompatible implants with magnetic resonance imaging
- Claustrophobia
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 |
|---|---|---|
| MRI in colon cancerThe MRI protocol will include the following imaging series: T1 and T2 in axial and coronal plane before the administration of intravenous contrast, diffuse weight imaging in axial plane and T1 after the administration of intravenous contrast | Diagnostic test | MRI in colon cancer |
| CT in colon cancerThe CT scan protocol will include the following: per os and intravenous administration of contrast, axial slices of 0.3mm thickness and reconstruction per 1mm, multi-planar reformation and three-dimensional volume rendering | Diagnostic test | MRI in colon cancer |
Primary outcome
Diagnostic accuracy in T stage
Time frame: 1 month postoperatively
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
3 secondary outcomes
Diagnostic accuracy in N stage
Time frame: 1 month postoperatively
Diagnostic accuracy in the retroperitoneal resection margin
Time frame: 1 month postoperatively
Diagnostic accuracy in peritoneal or nearby organ infiltration
Time frame: 1 month postoperatively
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 Oct 2023.
- Background: PubMed 26752945Xynos E, Gouvas N, Triantopoulou C, Tekkis P, Vini L, Tzardi M, Boukovinas I, Androulakis N, Athanasiadis A, Christodoulou C, Chrysou E, Dervenis C, Emmanouilidis C, Georgiou P, Katopodi O, Kountourakis P, Makatsoris T, Papakostas P, Papamichael D, Pentheroudakis G, Pilpilidis I, Sgouros J, Vassiliou V, Xynogalos S, Ziras N, Karachaliou N, Zoras O, Agalianos C, Souglakos J; [the Executive Team on behalf of the Hellenic Society of Medical Oncology (HeSMO)]. Clinical practice guidelines for the surgical management of colon cancer: a consensus statement of the Hellenic and Cypriot Colorectal Cancer Study Group by the HeSMO. Ann Gastroenterol. 2016 Jan-Mar;29(1):3-17.
- Background: PubMed 11309435Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96. doi: 10.1093/jnci/93.8.583.
- Background: PubMed 26102418Jhaveri KS, Hosseini-Nik H. MRI of Rectal Cancer: An Overview and Update on Recent Advances. AJR Am J Roentgenol. 2015 Jul;205(1):W42-55. doi: 10.2214/AJR.14.14201.
- Background: PubMed 23017669Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
- Background: PubMed 28267005Nerad E, Lambregts DM, Kersten EL, Maas M, Bakers FC, van den Bosch HC, Grabsch HI, Beets-Tan RG, Lahaye MJ. MRI for Local Staging of Colon Cancer: Can MRI Become the Optimal Staging Modality for Patients With Colon Cancer? Dis Colon Rectum. 2017 Apr;60(4):385-392. doi: 10.1097/DCR.0000000000000794.
- Background: PubMed 29627288Jacobs MA, Macura KJ, Zaheer A, Antonarakis ES, Stearns V, Wolff AC, Feiweier T, Kamel IR, Wahl RL, Pan L. Multiparametric Whole-body MRI with Diffusion-weighted Imaging and ADC Mapping for the Identification of Visceral and Osseous Metastases From Solid Tumors. Acad Radiol. 2018 Nov;25(11):1405-1414. doi: 10.1016/j.acra.2018.02.010. Epub 2018 Apr 4.
- Background: PubMed 25493009Kijima S, Sasaki T, Nagata K, Utano K, Lefor AT, Sugimoto H. Preoperative evaluation of colorectal cancer using CT colonography, MRI, and PET/CT. World J Gastroenterol. 2014 Dec 7;20(45):16964-75. doi: 10.3748/wjg.v20.i45.16964.
- Background: PubMed 14693872Antoch G, Vogt FM, Freudenberg LS, Nazaradeh F, Goehde SC, Barkhausen J, Dahmen G, Bockisch A, Debatin JF, Ruehm SG. Whole-body dual-modality PET/CT and whole-body MRI for tumor staging in oncology. JAMA. 2003 Dec 24;290(24):3199-206. doi: 10.1001/jama.290.24.3199.
- Background: PubMed 27226219Hunter C, Blake H, Jeyadevan N, Abulafi M, Swift I, Toomey P, Brown G. Local staging and assessment of colon cancer with 1.5-T magnetic resonance imaging. Br J Radiol. 2016 Aug;89(1064):20160257. doi: 10.1259/bjr.20160257. Epub 2016 May 26.
- Background: PubMed 28597000Ellebaek SB, Fristrup CW, Mortensen MB. Intraoperative Ultrasound as a Screening Modality for the Detection of Liver Metastases during Resection of Primary Colorectal Cancer - A Systematic Review. Ultrasound Int Open. 2017 Apr;3(2):E60-E68. doi: 10.1055/s-0043-100503. Epub 2017 Jun 7.
- Background: PubMed 26611110Elibol FD, Obuz F, Sokmen S, Terzi C, Canda AE, Sagol O, Sarioglu S. The role of multidetector CT in local staging and evaluation of retroperitoneal surgical margin involvement in colon cancer. Diagn Interv Radiol. 2016 Jan-Feb;22(1):5-12. doi: 10.5152/dir.2015.15089.
- Background: PubMed 15790712Bateman AC, Carr NJ, Warren BF. The retroperitoneal surface in distal caecal and proximal ascending colon carcinoma: the Cinderella surgical margin? J Clin Pathol. 2005 Apr;58(4):426-8. doi: 10.1136/jcp.2004.019802.
- Individual participant dataSharing planned: No. No plan to share individual patient data
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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.
George Tzovaras, Prof study chair
University Hospital of Larissa
Effrosyni Bompou, MSc principal investigator
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in colon cancer and CT in colon cancer in people with Colonic Neoplasms, run by Larissa University Hospital at 1 site in Greece.
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 4 inclusion and 9 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 Oct 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 Greece. 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?
Diagnostic accuracy in T stage (time frame: 1 month postoperatively). 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 NCT05727007, which also lists 15 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 Oct 2023.