Colon CancerNCT04666883
Splenic Hilar Nodes in Splenic Flexure Cancer
An observational study of Colon Cancer and Metastases, Lymphatic, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Metastases, Lymphatic
- What is being tested?
- Review of records and follow up
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cancer of the splenic flexure of the colon
Who may be able to join
- All splenic flexure cancer patients
Who cannot join
- No consent to data utilization
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico Tor Vergata
Roma, RM, 00133
Bruno Sensi, MD, +39 3385352902, brunosensi@outlook.it
Giuseppe S Sica, MD, PhD, +39 3385333659, sigisica@gmail.com
About this study
Official title: Aberrant Lympahtic Drainage of Splenic Flexure Cancer: Are Splenic Hilar Nodes Metastases an Underecognized Phenomenon?
Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.
- Conditions
- Colon Cancer, Metastases, Lymphatic
- Being tested
- Review of records and follow up
- Medical subject headings
- Colonic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of records and follow upOther
Follow up to identify patients who developed splenic hilar nodal metastases
| Study group | Role | What they receive |
|---|---|---|
| Splenic flexure cancer patients | Splenic flexure cancer patients Receives: Other: Review of records and follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Splenic hilum nodal metastases
Splenic hilum nodal metastases
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 posted14 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666883
- Sponsor's protocol ID
- REGISTROSPERIMENTAZIONI/21
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aberrant Lympahtic Drainage of Splenic Flexure Cancer: Are Splenic Hilar Nodes Metastases an Underecognized Phenomenon?
- ClinicalTrials.gov ID
- NCT04666883
- Acronym / sponsor ID
- REGISTROSPERIMENTAZIONI/21
- Conditions
- Colon Cancer, Metastases, Lymphatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 14 Dec 2020 (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.
Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Splenic flexure cancer patients | – | Other: Review of records and follow upSplenic flexure cancer patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cancer of the splenic flexure of the colon
Key inclusion criteria (1 listed)
- All splenic flexure cancer patients
Key exclusion criteria (1 listed)
- No consent to data utilization
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 |
|---|---|---|
| Review of records and follow upFollow up to identify patients who developed splenic hilar nodal metastases | Other | Splenic flexure cancer patients |
Primary outcome
Splenic hilum nodal metastases
Time frame: 5 years
Splenic hilum nodal metastases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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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.
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 Colon Cancer and Metastases, Lymphatic, run by University of Rome Tor Vergata at 1 site in Italy.
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 29 Dec 2020. 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 Italy. 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 Bruno Sensi, MD (3385352902, brunosensi@outlook.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splenic hilum nodal metastases (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 29 Dec 2020.