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Trial record 49 of 77033 for:    Neoplasms

Ploidy and Stroma in Early Rectal Cancer

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ClinicalTrials.gov Identifier: NCT03039595
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Chris Cunningham, Oxford University Hospitals NHS Trust

Brief Summary:
Early rectal cancer can be removed by minimally-invasive surgery, and the standard pathological assessment of the removed tumour gives valuable information about how advanced the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and patient can decide on the most appropriate further treatment and follow-up. However there is still much uncertainty in these predictions about recurrence. This study will assess two further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results with outcome. This will determine whether these two tests provide additional value in predicting outcome. If so, clinicians would be better able to advise patients with early rectal cancer about their prognosis and further management.

Condition or disease Intervention/treatment
Rectal Cancer Other: Ploidy and tumour:stromal ratio measurements

Detailed Description:

Early rectal cancer can be removed by minimally-invasive surgery, and the standard pathological assessment of the removed tumour gives valuable information about how advanced the tumour is. This information is very important in indicating whether the cancer is likely to recur, and therefore in advising the patient after surgery whether further treatment is advisable, and if not, what is the most appropriate follow-up regime. However there is still a lot of uncertainty in these predictions about recurrence of the cancer, and better tests are being sought. This study aims to look at two further pathology tests, ploidy and stroma ratio in the tumour, and correlate these test results with outcome in patients who have had an early rectal cancer removed. This will allow the investigators to assess whether these two tests provide additional value in predicting outcome. If so, clinicians would be better able to advise patients with early rectal cancer about their prognosis and further management.

Routine histopathology analysis of a rectal cancer specimen removed at surgery includes assessment of tumour size, depth of invasion, vascular, lymphatic and perineural invasion, tumour involvement of resection margins and nodal involvement. This information is valuable in predicting outcome. For example, predicted rates of local recurrence at 36 months following local excision of rectal cancer by transanal endoscopic microsurgery (TEM) based on tumour size, depth of invasion and lymphatic invasion have been tabulated. However such models are not perfect, and leave room for improvement. Ploidy and stroma ratio are two further tests which have shown some promise in predicting outcome.

Ploidy refers to the number of sets of chromosomes in a cell nucleus. Most human cells are normally diploid, with two sets of 23 chromosomes. Abnormal tumour cells may have a different number of sets of chromosomes, or be aneuploid, having some replicated or deleted chromosomes. In general, aneuploidy in cancer cells is associated with a worse prognosis. An early study of DNA ploidy in rectal cancer using flow cytometry showed an independent but small predictive effective of aneuploidy on survival. Technological advances now allow more accurate and detailed assessment of ploidy. The DNA ploidy status of tumour cells in early ovarian cancer has been found to predict which patients will benefit from adjuvant chemotherapy after surgery to remove the ovarian tumour and is used routinely in some centres to aid in decision-making.

Stroma ratio refers to the tumour: stroma ratio. A lower proportion of tumour cells or, conversely, a higher percentage of stroma, in a cancer tends to be associated with a poorer prognosis. This ratio has been found to be strongly associated with tumour growth and invasion in colorectal cancers, and to independently predict survival in patients undergoing surgery to removal colorectal tumours. However previous studies have looked mainly at more advanced colon cancers, rather than early rectal cancers, and have used only cancer-related death as the endpoint, rather than looking at local recurrence and response to adjuvant treatments.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Observational Study to Correlate the Results of Ploidy and Stroma Analysis With Prognosis in Early Rectal Cancer
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Intervention Details:
  • Other: Ploidy and tumour:stromal ratio measurements
    Ploidy and tumour:stromal ratio measurements will be made on specimens of early rectal cancer removed by transanal endoscopic microsurgery (TEM)


Primary Outcome Measures :
  1. Correlation between [A] ploidy status and [B] tumour: stroma ratio with local recurrence of cancer [ Time Frame: a minimum of 6 months after surgery ]
    Results of ploidy status and tumour:stromal ratio will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation with local recurrence of the rectal cancer


Secondary Outcome Measures :
  1. Correlation between [A] ploidy and [B] stroma analysis with overall survival after TEM surgery to remove rectal cancer [ Time Frame: a minimum of 6 months after surgery ]
    Results of ploidy status and tumour:stromal ratio will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation between the test results and overall survival

  2. Contribution of [A] ploidy and [B] stroma analysis to a regression model for local recurrence after TEM surgery to remove rectal cancer [ Time Frame: a minimum of 6 months after surgery ]
    A regression model will be developed looking at local recurrence of rectal cancer after TEM surgery, and we will assess whether ploidy and stroma are significant variables in this

  3. Subgroup analysis comparing [A] ploidy and [B] stroma results with local recurrence and survival for patients who did and did not receive adjuvant chemo- or radiotherapy [ Time Frame: a minimum of 6 months after surgery ]
    A subgroup analysis will correlate local recurrence and survival with the ploidy and stroma test results, in the groups that had and did not have post-operative adjuvant chemo- or radiotherapy


Biospecimen Retention:   Samples Without DNA
Specimens of early rectal cancer removed by transanal endoscopic microsurgery, which are routinely retained, will be further analysed.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with rectal cancer that is operable and patients who have already had rectal cancer removed by transanal endoscopic microsurgery (TEM) in Oxford since 2007.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent (in English) for participation in the study, or gave informed consent for donation of tissue for research at the time of surgery
  • Male or Female, aged 18 years or above
  • Diagnosed with operable rectal cancer
  • Due to undergo, or has already undergone, TEM surgery to remove rectal cancer
  • A useable tissue sample has already been, or will be, taken as part of routine surgery

Exclusion Criteria:

  • Age less than 18
  • Adults who are not able to give consent or who are deemed vulnerable
  • Participants who do not have a useable tissue sample will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039595


Locations
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United Kingdom
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Oslo University Hospital
Investigators
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Principal Investigator: Chris Cunningham, MD Employee

Publications:

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Responsible Party: Chris Cunningham, Consultant colorectal surgeon, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03039595     History of Changes
Other Study ID Numbers: 11846
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data will be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chris Cunningham, Oxford University Hospitals NHS Trust:
Early rectal cancer
Ploidy
Tumour:stroma ratio

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases