the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatmentNCT05673343
The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer
An observational study of the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment, run by Assiut University.
Trial summary
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2023to 1 Mar 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function. 5- Performance status 0-1 according to ECOG PS
Who may be able to join
- Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.
- 5- Performance status 0-1 according to ECOG PS
Who cannot join
- 1- metastatic disease 2- Younger than 18 year old 3-Any other malignancy 4-There is contraindication for CCRT
About this study
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment
Read the detailed description
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.[1] Rectal cancer accounts for 30% to 35% of CRCs[2], Between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (LARC),[3] Useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. Such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.[4]
Inflammation-induced markers play an important role in tumorigenesis and tumor progression. More evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.[4] Two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. Increased NLR has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, CRC, and gastric cancer [5-6].
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Complete blood count | Complete blood count with differential should be done within 2 weeks before starting CCRT. We will calculate NLR as total neutrophilic count divided by total lymphocytic count for each patient before starting the treatment. Two protocols of the treatment: first is by starting with CCRT then surgery (Total Neoadjuvant Therapy), second is CCRT then surgery then continue chemotherapy: FOLFOX , Xeloda or CAPOX. Radiotherapy dose: long course radiation therapy at the dose of 45 to 50 Gray (Gy) in 25 to 28 fractions to the pelvis by NCCN recommendation. Short-course radiation therapy (25 Gy in 5 fractions). Patients should be kept on follow up after complete their treatment every three months till disease progression occur, death of the patient or at least 12 months of follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free-survival
defined as the time from the day of disease diagnosis until the day of disease failure.
Measured: 2-5 yrs
Secondary outcomes (1)
overall survival (OS
defined as the time from the day of disease diagnosis until the date of death.
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start4 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa tarek shafea, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673343
- Sponsor's protocol ID
- Locally advanced rectal cancer
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang G, Chang JS, Choi JE, Baek ES, Kim SS, Byun HK, Cho Y, Koom WS, Yang SY, Min BS, Shin SJ. Association of neutrophil-to-lymphocyte ratio, radiotherapy fractionation/technique, and risk of development of distant metastasis among patients with locally advanced rectal cancer. Radiat Oncol. 2022 May 21;17(1):100. doi: 10.1186/s13014-022-02065-8.
PubMed 35597954Nagasaki T, Akiyoshi T, Fujimoto Y, Konishi T, Nagayama S, Fukunaga Y, Ueno M. Prognostic Impact of Neutrophil-to-Lymphocyte Ratio in Patients with Advanced Low Rectal Cancer Treated with Preoperative Chemoradiotherapy. Dig Surg. 2015;32(6):496-503. doi: 10.1159/000441396. Epub 2015 Nov 7.
PubMed 26544755Sun Y, Zhang Y, Huang Z, Lin H, Lu X, Huang Y, Chi P. Combination of Preoperative Plasma Fibrinogen and Neutrophil-to-Lymphocyte Ratio (the F-NLR Score) as a Prognostic Marker of Locally Advanced Rectal Cancer Following Preoperative Chemoradiotherapy. World J Surg. 2020 Jun;44(6):1975-1984. doi: 10.1007/s00268-020-05407-3.
PubMed 32020327Cha YJ, Park EJ, Baik SH, Lee KY, Kang J. Prognostic impact of persistent lower neutrophil-to-lymphocyte ratio during preoperative chemoradiotherapy in locally advanced rectal cancer patients: A propensity score matching analysis. PLoS One. 2019 Mar 22;14(3):e0214415. doi: 10.1371/journal.pone.0214415. eCollection 2019.
PubMed 30901357Toiyama Y, Inoue Y, Kawamura M, Kawamoto A, Okugawa Y, Hiro J, Saigusa S, Tanaka K, Mohri Y, Kusunoki M. Elevated platelet count as predictor of recurrence in rectal cancer patients undergoing preoperative chemoradiotherapy followed by surgery. Int Surg. 2015 Feb;100(2):199-207. doi: 10.9738/INTSURG-D-13-00178.1.
PubMed 25692418
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05673343
- Acronym / sponsor ID
- Locally advanced rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 Jan 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.
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment
Detailed description
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.[1] Rectal cancer accounts for 30% to 35% of CRCs[2], Between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (LARC),[3] Useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. Such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.[4]
Inflammation-induced markers play an important role in tumorigenesis and tumor progression. More evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.[4] Two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. Increased NLR has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, CRC, and gastric cancer [5-6].
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete blood count | – | –Complete blood count with differential should be done within 2 weeks before starting CCRT. We will calculate NLR as total neutrophilic count divided by total lymphocytic count for each patient before starting the treatment. Two protocols of the treatment: first is by starting with CCRT then surgery (Total Neoadjuvant Therapy), second is CCRT then surgery then continue chemotherapy: FOLFOX , Xeloda or CAPOX. Radiotherapy dose: long course radiation therapy at the dose of 45 to 50 Gray (Gy) in 25 to 28 fractions to the pelvis by NCCN recommendation. Short-course radiation therapy (25 Gy in 5 fractions). Patients should be kept on follow up after complete their treatment every three months till disease progression occur, death of the patient or at least 12 months of follow up. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function. 5- Performance status 0-1 according to ECOG PS
Key inclusion criteria (2 listed)
- Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.
- 5- Performance status 0-1 according to ECOG PS
Key exclusion criteria (1 listed)
- 1- metastatic disease 2- Younger than 18 year old 3-Any other malignancy 4-There is contraindication for CCRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease free-survival
Time frame: 2-5 yrs
defined as the time from the day of disease diagnosis until the day of disease failure.
1 secondary outcome
overall survival (OS
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 35597954Yang G, Chang JS, Choi JE, Baek ES, Kim SS, Byun HK, Cho Y, Koom WS, Yang SY, Min BS, Shin SJ. Association of neutrophil-to-lymphocyte ratio, radiotherapy fractionation/technique, and risk of development of distant metastasis among patients with locally advanced rectal cancer. Radiat Oncol. 2022 May 21;17(1):100. doi: 10.1186/s13014-022-02065-8.
- Background: PubMed 26544755Nagasaki T, Akiyoshi T, Fujimoto Y, Konishi T, Nagayama S, Fukunaga Y, Ueno M. Prognostic Impact of Neutrophil-to-Lymphocyte Ratio in Patients with Advanced Low Rectal Cancer Treated with Preoperative Chemoradiotherapy. Dig Surg. 2015;32(6):496-503. doi: 10.1159/000441396. Epub 2015 Nov 7.
- Background: PubMed 32020327Sun Y, Zhang Y, Huang Z, Lin H, Lu X, Huang Y, Chi P. Combination of Preoperative Plasma Fibrinogen and Neutrophil-to-Lymphocyte Ratio (the F-NLR Score) as a Prognostic Marker of Locally Advanced Rectal Cancer Following Preoperative Chemoradiotherapy. World J Surg. 2020 Jun;44(6):1975-1984. doi: 10.1007/s00268-020-05407-3.
- Background: PubMed 30901357Cha YJ, Park EJ, Baik SH, Lee KY, Kang J. Prognostic impact of persistent lower neutrophil-to-lymphocyte ratio during preoperative chemoradiotherapy in locally advanced rectal cancer patients: A propensity score matching analysis. PLoS One. 2019 Mar 22;14(3):e0214415. doi: 10.1371/journal.pone.0214415. eCollection 2019.
- Results publication: PubMed 25692418Toiyama Y, Inoue Y, Kawamura M, Kawamoto A, Okugawa Y, Hiro J, Saigusa S, Tanaka K, Mohri Y, Kusunoki M. Elevated platelet count as predictor of recurrence in rectal cancer patients undergoing preoperative chemoradiotherapy followed by surgery. Int Surg. 2015 Feb;100(2):199-207. doi: 10.9738/INTSURG-D-13-00178.1.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment, run by Assiut University.
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 2 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
disease free-survival (time frame: 2-5 yrs). 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 NCT05673343, which also lists 5 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 6 Jan 2023.