Colorectal Cancer RecurrentENCORENCT06271980
Early-Onset Colorectal Cancer Recurrence
An observational study of Colorectal Cancer Recurrent and Colorectal Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer Recurrent, Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- ENCORE
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 1 Feb 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Two independent cohorts of early-onset colorectal cancer survivors (stages I-III)
Who may be able to join
- Stage I, II, or III colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50
- Received standard diagnostic, staging, and therapeutic procedures as per local guidelines, received stage-specific curative-intent resection (with or without systemic therapy, as appropriate)
- Confirmed cancer-free survivors at the time of study inclusion
Who cannot join
- Hereditary colorectal cancer syndromes (identified through genetic testing)
- Inflammatory bowel diseases
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Predicting Long-Term Recurrence-Free and Overall Survival in Early-Onset Colorectal Cancer Survivors
Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.
This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid)
Read the detailed description
Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men in the US and the second for young women. In the wake of the increasing incidence, the growing population of EOCRC survivors introduces distinctive clinical challenges.
Patients with EOCRC are hypothesized to possess a more biologically active colorectum, susceptible to malignant transformation both earlier in life and later after primary cancer. Indeed, EOCRC survivors encounter an elevated risk of disease recurrence, a risk that may manifest years after primary treatment. These considerations have prompted a trend toward offering more aggressive therapy or endoscopy surveillance, a practice however not substantiated by evidence yet. Scientific societies have also adopted a cautious stance, recognizing the elevated risk while acknowledging the absence of evidence to substantiate an intensified surveillance protocol, which might constitute overtreatment.
In this research effort, the investigators will leverage machine learning to predict recurrence-free survival (RFS) and overall survival (OS) in patients cured of EOCRC. The research plan will employ three phases:
- After a systematic discovery phase, based on small RNA sequencing, the investigators will identify a panel of candidate biomarkers.
- The investigators will then develop an assay based on reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and train a machine-learning model to predict recurrence-free and overall survival outcomes
- The investigators will independently validate the assay.
This assay is provisionally termed "ENCORE" (Early oNset COlorectal cancer REcurrence) and will be tested for recurrence-free and overall survival outcomes up to ten years after treatment.
At the end of this study, this assay will have been developed and validated to help clinical decision-making by predicting both recurrence-free and overall survival in EOCRC survivors.
- Conditions
- Colorectal Cancer Recurrent, Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenocarcinoma, Colorectal Cancer Stage I, Colorectal Cancer Stage II
- Being tested
- ENCORE
- Keywords
- Early-Onset, Young-Onset, Surveillance, micro-RNA, Prediction
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENCOREOther
Also called ENCORE (Early oNset COlorectal cancer REcurrence)
A panel of microRNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
| Study group | Role | What they receive |
|---|---|---|
| Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort) | Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort Receives: Other: ENCORE | |
| Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort) | Survivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort Receives: Other: ENCORE | |
| Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort) | Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort Receives: Other: ENCORE | |
| Survivors of early-onset colorectal cancer, with no recurrent disease (Validation Cohort) | Survivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort Receives: Other: ENCORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
Time from disease treatment to development of recurrent colorectal cancer
Measured: Up to 120 months
Secondary outcomes (1)
Overall Survival
Time from disease treatment to death from any cause
Measured: Up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Apr 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, Institute of Biomedical Research of Salamanca, Salamanca, Spain
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271980
- Sponsor's protocol ID
- 23228/ENCORE
- Acronym
- ENCORE
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
Publications
Sinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available.
PubMed 35443109Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
PubMed 36856579Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
PubMed 38230766Kim TJ, Kim ER, Hong SN, Chang DK, Kim YH. Long-Term Outcome and Prognostic Factors of Sporadic Colorectal Cancer in Young Patients: A Large Institutional-Based Retrospective Study. Medicine (Baltimore). 2016 May;95(19):e3641. doi: 10.1097/MD.0000000000003641.
PubMed 27175682You YN, Dozois EJ, Boardman LA, Aakre J, Huebner M, Larson DW. Young-onset rectal cancer: presentation, pattern of care and long-term oncologic outcomes compared to a matched older-onset cohort. Ann Surg Oncol. 2011 Sep;18(9):2469-76. doi: 10.1245/s10434-011-1674-7. Epub 2011 Mar 30.
PubMed 21448750Foppa C, Tamburello S, Maroli A, Carvello M, Poliani L, Laghi L, Malesci A, Montorsi M, Perea J, Spinelli A. Early age of onset is an independent predictor for worse disease-free survival in sporadic rectal cancer patients. A comparative analysis of 980 consecutive patients. Eur J Surg Oncol. 2022 Apr;48(4):857-863. doi: 10.1016/j.ejso.2021.10.021. Epub 2021 Oct 28.
PubMed 34740480Kim SB, Lee HJ, Park SJ, Hong SP, Cheon JH, Kim WH, Kim TI. Comparison of Colonoscopy Surveillance Outcomes Between Young and Older Colorectal Cancer Patients. J Cancer Prev. 2017 Sep;22(3):159-165. doi: 10.15430/JCP.2017.22.3.159. Epub 2017 Sep 30.
PubMed 29018780Chen FW, Sundaram V, Chew TA, Ladabaum U. Advanced-Stage Colorectal Cancer in Persons Younger Than 50 Years Not Associated With Longer Duration of Symptoms or Time to Diagnosis. Clin Gastroenterol Hepatol. 2017 May;15(5):728-737.e3. doi: 10.1016/j.cgh.2016.10.038. Epub 2016 Nov 14.
PubMed 27856366Al Maliki H, Monahan KJ. The diagnostic yield of colonoscopic surveillance following resection of early age onset colorectal cancer. United European Gastroenterol J. 2024 May;12(4):469-476. doi: 10.1002/ueg2.12516. Epub 2024 Jan 3.
PubMed 38170450Peacock O, Vilar E, Guraieb-Trueba M, Thirumurthi S, Chang GJ, You YN. Clinically Significant Metachronous Colorectal Pathology Detected Among Young-Onset Colorectal Cancer Survivors: Implications for Post-Resection Surveillance Guidelines. Gastroenterology. 2022 Dec;163(6):1682-1684.e2. doi: 10.1053/j.gastro.2022.08.030. Epub 2022 Aug 17. No abstract available.
PubMed 35987446Zaborowski AM, Murphy B, Creavin B, Rogers AC, Kennelly R, Hanly A, Martin ST, O'Connell PR, Sheahan K, Winter DC. Clinicopathological features and oncological outcomes of patients with young-onset rectal cancer. Br J Surg. 2020 Apr;107(5):606-612. doi: 10.1002/bjs.11526. Epub 2020 Mar 9.
PubMed 32149397Bouvier AM, Latournerie M, Jooste V, Lepage C, Cottet V, Faivre J. The lifelong risk of metachronous colorectal cancer justifies long-term colonoscopic follow-up. Eur J Cancer. 2008 Mar;44(4):522-7. doi: 10.1016/j.ejca.2008.01.007. Epub 2008 Feb 5.
PubMed 18255278Monahan KJ, Bradshaw N, Dolwani S, Desouza B, Dunlop MG, East JE, Ilyas M, Kaur A, Lalloo F, Latchford A, Rutter MD, Tomlinson I, Thomas HJW, Hill J; Hereditary CRC guidelines eDelphi consensus group. Guidelines for the management of hereditary colorectal cancer from the British Society of Gastroenterology (BSG)/Association of Coloproctology of Great Britain and Ireland (ACPGBI)/United Kingdom Cancer Genetics Group (UKCGG). Gut. 2020 Mar;69(3):411-444. doi: 10.1136/gutjnl-2019-319915. Epub 2019 Nov 28.
PubMed 31780574Rutter MD, East J, Rees CJ, Cripps N, Docherty J, Dolwani S, Kaye PV, Monahan KJ, Novelli MR, Plumb A, Saunders BP, Thomas-Gibson S, Tolan DJM, Whyte S, Bonnington S, Scope A, Wong R, Hibbert B, Marsh J, Moores B, Cross A, Sharp L. British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines. Gut. 2020 Feb;69(2):201-223. doi: 10.1136/gutjnl-2019-319858. Epub 2019 Nov 27.
PubMed 31776230Cavestro GM, Mannucci A, Balaguer F, Hampel H, Kupfer SS, Repici A, Sartore-Bianchi A, Seppala TT, Valentini V, Boland CR, Brand RE, Buffart TE, Burke CA, Caccialanza R, Cannizzaro R, Cascinu S, Cercek A, Crosbie EJ, Danese S, Dekker E, Daca-Alvarez M, Deni F, Dominguez-Valentin M, Eng C, Goel A, Guillem JG, Houwen BBSL, Kahi C, Kalady MF, Kastrinos F, Kuhn F, Laghi L, Latchford A, Liska D, Lynch P, Malesci A, Mauri G, Meldolesi E, Moller P, Monahan KJ, Moslein G, Murphy CC, Nass K, Ng K, Oliani C, Papaleo E, Patel SG, Puzzono M, Remo A, Ricciardiello L, Ripamonti CI, Siena S, Singh SK, Stadler ZK, Stanich PP, Syngal S, Turi S, Urso ED, Valle L, Vanni VS, Vilar E, Vitellaro M, You YN, Yurgelun MB, Zuppardo RA, Stoffel EM; Associazione Italiana Familiarita Ereditarieta Tumori; Collaborative Group of the Americas on Inherited Gastrointestinal Cancer; European Hereditary Tumour Group, and the International Society for Gastrointestinal Hereditary Tumours. Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines. Clin Gastroenterol Hepatol. 2023 Mar;21(3):581-603.e33. doi: 10.1016/j.cgh.2022.12.006. Epub 2022 Dec 20.
PubMed 36549470
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Long-Term Recurrence-Free and Overall Survival in Early-Onset Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT06271980
- Acronym / sponsor ID
- ENCORE / 23228/ENCORE
- Conditions
- Colorectal Cancer Recurrent, Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenocarcinoma, Colorectal Cancer Stage I, Colorectal Cancer Stage II
- Keywords
- Early-Onset, Young-Onset, Surveillance, micro-RNA, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, Institute of Biomedical Research of Salamanca, Salamanca, Spain
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Feb 2024 (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.
Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.
This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid)
Detailed description
Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men in the US and the second for young women. In the wake of the increasing incidence, the growing population of EOCRC survivors introduces distinctive clinical challenges.
Patients with EOCRC are hypothesized to possess a more biologically active colorectum, susceptible to malignant transformation both earlier in life and later after primary cancer. Indeed, EOCRC survivors encounter an elevated risk of disease recurrence, a risk that may manifest years after primary treatment. These considerations have prompted a trend toward offering more aggressive therapy or endoscopy surveillance, a practice however not substantiated by evidence yet. Scientific societies have also adopted a cautious stance, recognizing the elevated risk while acknowledging the absence of evidence to substantiate an intensified surveillance protocol, which might constitute overtreatment.
In this research effort, the investigators will leverage machine learning to predict recurrence-free survival (RFS) and overall survival (OS) in patients cured of EOCRC. The research plan will employ three phases:
- After a systematic discovery phase, based on small RNA sequencing, the investigators will identify a panel of candidate biomarkers.
- The investigators will then develop an assay based on reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and train a machine-learning model to predict recurrence-free and overall survival outcomes
- The investigators will independently validate the assay.
This assay is provisionally termed "ENCORE" (Early oNset COlorectal cancer REcurrence) and will be tested for recurrence-free and overall survival outcomes up to ten years after treatment.
At the end of this study, this assay will have been developed and validated to help clinical decision-making by predicting both recurrence-free and overall survival in EOCRC survivors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort) | – | Other: ENCORESurvivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort |
| Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort) | – | Other: ENCORESurvivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort |
| Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort) | – | Other: ENCORESurvivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort |
| Survivors of early-onset colorectal cancer, with no recurrent disease (Validation Cohort) | – | Other: ENCORESurvivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Two independent cohorts of early-onset colorectal cancer survivors (stages I-III)
Key inclusion criteria (3 listed)
- Stage I, II, or III colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50
- Received standard diagnostic, staging, and therapeutic procedures as per local guidelines, received stage-specific curative-intent resection (with or without systemic therapy, as appropriate)
- Confirmed cancer-free survivors at the time of study inclusion
Key exclusion criteria (3 listed)
- Hereditary colorectal cancer syndromes (identified through genetic testing)
- Inflammatory bowel diseases
- Lack of written 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 |
|---|---|---|
| ENCOREAlso: ENCORE (Early oNset COlorectal cancer REcurrence)A panel of microRNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor. | Other | Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort), Survivors of early-onset colorectal cancer, with no recurrent disease (Validation Cohort), Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort), Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort) |
Primary outcome
Recurrence Free Survival
Time frame: Up to 120 months
Time from disease treatment to development of recurrent colorectal cancer
1 secondary outcome
Overall Survival
Time frame: Up to 120 months
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 12 Mar 2024.
- Background: PubMed 35443109Sinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available.
- Background: PubMed 36856579Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
- Background: PubMed 38230766Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
- Background: PubMed 27175682Kim TJ, Kim ER, Hong SN, Chang DK, Kim YH. Long-Term Outcome and Prognostic Factors of Sporadic Colorectal Cancer in Young Patients: A Large Institutional-Based Retrospective Study. Medicine (Baltimore). 2016 May;95(19):e3641. doi: 10.1097/MD.0000000000003641.
- Background: PubMed 21448750You YN, Dozois EJ, Boardman LA, Aakre J, Huebner M, Larson DW. Young-onset rectal cancer: presentation, pattern of care and long-term oncologic outcomes compared to a matched older-onset cohort. Ann Surg Oncol. 2011 Sep;18(9):2469-76. doi: 10.1245/s10434-011-1674-7. Epub 2011 Mar 30.
- Background: PubMed 34740480Foppa C, Tamburello S, Maroli A, Carvello M, Poliani L, Laghi L, Malesci A, Montorsi M, Perea J, Spinelli A. Early age of onset is an independent predictor for worse disease-free survival in sporadic rectal cancer patients. A comparative analysis of 980 consecutive patients. Eur J Surg Oncol. 2022 Apr;48(4):857-863. doi: 10.1016/j.ejso.2021.10.021. Epub 2021 Oct 28.
- Background: PubMed 29018780Kim SB, Lee HJ, Park SJ, Hong SP, Cheon JH, Kim WH, Kim TI. Comparison of Colonoscopy Surveillance Outcomes Between Young and Older Colorectal Cancer Patients. J Cancer Prev. 2017 Sep;22(3):159-165. doi: 10.15430/JCP.2017.22.3.159. Epub 2017 Sep 30.
- Background: PubMed 27856366Chen FW, Sundaram V, Chew TA, Ladabaum U. Advanced-Stage Colorectal Cancer in Persons Younger Than 50 Years Not Associated With Longer Duration of Symptoms or Time to Diagnosis. Clin Gastroenterol Hepatol. 2017 May;15(5):728-737.e3. doi: 10.1016/j.cgh.2016.10.038. Epub 2016 Nov 14.
- Background: PubMed 38170450Al Maliki H, Monahan KJ. The diagnostic yield of colonoscopic surveillance following resection of early age onset colorectal cancer. United European Gastroenterol J. 2024 May;12(4):469-476. doi: 10.1002/ueg2.12516. Epub 2024 Jan 3.
- Background: PubMed 35987446Peacock O, Vilar E, Guraieb-Trueba M, Thirumurthi S, Chang GJ, You YN. Clinically Significant Metachronous Colorectal Pathology Detected Among Young-Onset Colorectal Cancer Survivors: Implications for Post-Resection Surveillance Guidelines. Gastroenterology. 2022 Dec;163(6):1682-1684.e2. doi: 10.1053/j.gastro.2022.08.030. Epub 2022 Aug 17. No abstract available.
- Background: PubMed 32149397Zaborowski AM, Murphy B, Creavin B, Rogers AC, Kennelly R, Hanly A, Martin ST, O'Connell PR, Sheahan K, Winter DC. Clinicopathological features and oncological outcomes of patients with young-onset rectal cancer. Br J Surg. 2020 Apr;107(5):606-612. doi: 10.1002/bjs.11526. Epub 2020 Mar 9.
- Background: PubMed 18255278Bouvier AM, Latournerie M, Jooste V, Lepage C, Cottet V, Faivre J. The lifelong risk of metachronous colorectal cancer justifies long-term colonoscopic follow-up. Eur J Cancer. 2008 Mar;44(4):522-7. doi: 10.1016/j.ejca.2008.01.007. Epub 2008 Feb 5.
- Individual participant dataSharing planned: No. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such 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.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
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 Recurrent and Colorectal Cancer, run by City of Hope Medical Center at 1 site in United States.
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 12 Mar 2024. 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 United States. 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?
Recurrence Free Survival (time frame: Up to 120 months). 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 NCT06271980, which also lists 19 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 12 Mar 2024.