Colorectal CancerNCT07523919
Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes
An observational study of Colorectal Cancer and Respiratory Function, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Respiratory Function, Functional Status
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 10 Mar 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients aged 18-80 years diagnosed with colorectal cancer and scheduled for surgical treatment. All participants undergo preoperative assessment, including evaluation of functional status and respiratory parameters such as the Six-Minute Walk Test (6MWT) and pulmonary function tests. Patients with conditions that may interfere with test performance, including significant musculoskeletal, cognitive, or psychiatric disorders, as well as those with a history of major surgery, are excluded. Participants are followed longitudinally to assess long-term clinical outcomes.
Who may be able to join
- Age between 18 and 80 years
- Voluntary participation in the study
Who cannot join
- Presence of musculoskeletal disorders that may prevent completion of the required tests
- Presence of cognitive impairment
- History of psychiatric disease
- History of major surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İnönü University Turgut Özal Medical Center General Surgery Polyclinic
Merkez, Gümüşhane Province, 29000
MÜŞERREF EBRU YALÇIN, +905557136666, M.ebrusen@gmail.com
About this study
Official title: The Impact of Functional Status and Respiratory Parameters on Long-Term Outcomes in Colorectal Cancer
Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Patients diagnosed at an early stage and treated with surgery have significantly better long-term survival outcomes. Five-year survival rates are approximately 90% for stage I disease, decreasing to around 70% in stage II and 60% in stage III, and dropping to as low as 8% in stage IV disease.
Advanced age, family history, and environmental exposures are well-established risk factors for colorectal cancer. In addition, modifiable lifestyle factors-including smoking, physical inactivity, unhealthy dietary patterns, and obesity-have been shown to significantly increase the risk of disease.
Read more
Although surgical resection remains the cornerstone of curative treatment in colorectal cancer, long-term outcomes are influenced not only by tumor stage but also by various patient-related factors, including comorbidities, functional capacity, and respiratory reserve. Functional status, which reflects a patient's ability to perform activities of daily living, is a key determinant of postoperative recovery and long-term outcomes. Reduced functional capacity has been associated with poorer long-term survival, diminished quality of life, and increased late morbidity. Therefore, objective preoperative assessment of functional status is considered essential for predicting long-term prognosis.
Respiratory function also plays a critical role, particularly in patients undergoing abdominal surgery. Impaired pulmonary capacity increases the risk of postoperative pulmonary complications, prolongs hospital stay, and may indirectly affect long-term survival. However, studies evaluating the impact of preoperative respiratory parameters on long-term outcomes in patients with colorectal cancer remain limited. Furthermore, comprehensive analyses integrating both functional capacity and respiratory function are scarce in the current literature. Therefore, further investigation in this area is warranted.
The aim of this study is to evaluate the impact of functional status and respiratory parameters on long-term clinical outcomes in patients with colorectal cancer.
H0: There is no statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
H1: There is a statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
- Conditions
- Colorectal Cancer, Respiratory Function, Functional Status, Long Term
- Medical subject headings
- Colorectal Neoplasms, Respiratory Aspiration
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 |
|---|---|---|
| Colorectal Cancer Patients | This cohort consists of patients with colorectal cancer undergoing surgical treatment. Functional status and respiratory parameters are assessed preoperatively, and patients are followed to evaluate long-term clinical outcomes. No additional intervention beyond standard care is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Mar 2026
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Inonu 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
- 52 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müşerref Ebru YALÇIN, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523919
- Sponsor's protocol ID
- 2026/9561
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
9. Mima, K., Kosumi, K., Miyanari, N., Tajiri, T., Kanemitsu, K., Takematsu, T., … Baba, H. (2021). Impairment of activities of daily living is an independent risk factor for recurrence and mortality following curative resection of stage I-III colorectal cancer. Journal of Gastrointestinal Surgery, 25(10), 2628-2636. 10. Overcash, J. (2015). Assessing the functional status of older cancer patients in an ambulatory care visit. Healthcare, 3(3), 846-859. 11. Takahashi, K., Chiba, K., Honda, A., Iizuka, Y., Yoshinaga, K., Deo, A. S., & Uchida, T. (2025). Pre-operative subjective functional capacity and postoperative outcomes in adult non-cardiac surgery: A systematic review and meta-analysis. Anaesthesia, 80(5), 561-571. 12. Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA, 273(1), 59-65. 13. Minnella, E. M., Liberman, A. S., Charlebois, P., Stein, B., Scheede-Bergdahl, C., Awasthi, R., … Carli, F. (2019). The impact of improved functional capacity before surgery on postoperative complications: A study in colorectal cancer. Acta Oncologica, 58(5), 573-578. 14. Sánchez-Torralvo, F. J., González-Poveda, I., García-Olivares, M., Porras, N., Gonzalo-Marín, M., Tapia, M. J., … Olveira, G. (2022). Poor physical performance is associated with postoperative complications and mortality in preoperative patients with colorectal cancer. Nutrients, 14(7), 1484.
1. Mao, J. X., Gao, R., Wang, Y., Yan, X. B., & Wang, H. H. (2025). Surgical treatment of colorectal cancer: A multidimensional review. World Journal of Gastrointestinal Surgery, 17(8), 107785. 2. Pickhardt, P. J., Kim, D. H., Pooler, B. D., Hinshaw, J. L., Barlow, D., & Mccoy, A. (2011). Colorectal cancer: CT colonography and colonoscopy for detection-Systematic review and meta-analysis. Radiology, 259(2), 393-405. 3. Toma, M., Beluşică, L., Stavarachi, M., Apostol, P., Spandole, S., Radu, I., & Cimponeriu, D. (2012). Rating the environmental and genetic risk factors for colorectal cancer. Journal of Medicine and Life, 5(Special Issue), 152-159. 4. Carr, P. R., Weigl, K., Jansen, L., Walter, V., Erben, V., Chang-Claude, J., Brenner, H., & Hoffmeister, M. (2018). Healthy lifestyle factors associated with lower risk of colorectal cancer irrespective of genetic risk. Gastroenterology, 155(6), 1805-1815.e5. 5. de Nes, L. C. F. (2025). Assessment and improvement of quality of care in colorectal cancer surgery (Doctoral dissertation). 6. Tomruk, M., Karadibak, D., Yavuzşen, T., & Akman, T. (2015). Predictors of functional capacity in colorectal cancer patients. Supportive Care in Cancer, 23(9), 2747-2754. 7. van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., … Slooter, G. (2019). Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: The first international randomized controlled trial for multimodal prehabilitation. BMC Cancer, 19(1), 98. 8. Whelan, M., van Aswegen, H., Roos, R., Fabian, J., & Bebington, B. (2021). Preoperative physical activity and functional performance levels are predictors of acute postoperative outcomes in a private South African colorectal cancer cohort. South African Journal of Physiotherapy, 77(1), 1526.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Functional Status and Respiratory Parameters on Long-Term Outcomes in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07523919
- Acronym / sponsor ID
- 2026/9561
- Conditions
- Colorectal Cancer, Respiratory Function, Functional Status, Long Term
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Patients diagnosed at an early stage and treated with surgery have significantly better long-term survival outcomes. Five-year survival rates are approximately 90% for stage I disease, decreasing to around 70% in stage II and 60% in stage III, and dropping to as low as 8% in stage IV disease.
Advanced age, family history, and environmental exposures are well-established risk factors for colorectal cancer. In addition, modifiable lifestyle factors-including smoking, physical inactivity, unhealthy dietary patterns, and obesity-have been shown to significantly increase the risk of disease.
Although surgical resection remains the cornerstone of curative treatment in colorectal cancer, long-term outcomes are influenced not only by tumor stage but also by various patient-related factors, including comorbidities, functional capacity, and respiratory reserve. Functional status, which reflects a patient's ability to perform activities of daily living, is a key determinant of postoperative recovery and long-term outcomes. Reduced functional capacity has been associated with poorer long-term survival, diminished quality of life, and increased late morbidity. Therefore, objective preoperative assessment of functional status is considered essential for predicting long-term prognosis.
Respiratory function also plays a critical role, particularly in patients undergoing abdominal surgery. Impaired pulmonary capacity increases the risk of postoperative pulmonary complications, prolongs hospital stay, and may indirectly affect long-term survival. However, studies evaluating the impact of preoperative respiratory parameters on long-term outcomes in patients with colorectal cancer remain limited. Furthermore, comprehensive analyses integrating both functional capacity and respiratory function are scarce in the current literature. Therefore, further investigation in this area is warranted.
The aim of this study is to evaluate the impact of functional status and respiratory parameters on long-term clinical outcomes in patients with colorectal cancer.
H0: There is no statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
H1: There is a statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Patients | – | –This cohort consists of patients with colorectal cancer undergoing surgical treatment. Functional status and respiratory parameters are assessed preoperatively, and patients are followed to evaluate long-term clinical outcomes. No additional intervention beyond standard care is performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients aged 18-80 years diagnosed with colorectal cancer and scheduled for surgical treatment. All participants undergo preoperative assessment, including evaluation of functional status and respiratory parameters such as the Six-Minute Walk Test (6MWT) and pulmonary function tests. Patients with conditions that may interfere with test performance, including significant musculoskeletal, cognitive, or psychiatric disorders, as well as those with a history of major surgery, are excluded. Participants are followed longitudinally to assess long-term clinical outcomes.
Key inclusion criteria (2 listed)
- Age between 18 and 80 years
- Voluntary participation in the study
Key exclusion criteria (4 listed)
- Presence of musculoskeletal disorders that may prevent completion of the required tests
- Presence of cognitive impairment
- History of psychiatric disease
- History of major surgery
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
Six-Minute Walk Test (6MWT)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication9. Mima, K., Kosumi, K., Miyanari, N., Tajiri, T., Kanemitsu, K., Takematsu, T., … Baba, H. (2021). Impairment of activities of daily living is an independent risk factor for recurrence and mortality following curative resection of stage I-III colorectal cancer. Journal of Gastrointestinal Surgery, 25(10), 2628-2636. 10. Overcash, J. (2015). Assessing the functional status of older cancer patients in an ambulatory care visit. Healthcare, 3(3), 846-859. 11. Takahashi, K., Chiba, K., Honda, A., Iizuka, Y., Yoshinaga, K., Deo, A. S., & Uchida, T. (2025). Pre-operative subjective functional capacity and postoperative outcomes in adult non-cardiac surgery: A systematic review and meta-analysis. Anaesthesia, 80(5), 561-571. 12. Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA, 273(1), 59-65. 13. Minnella, E. M., Liberman, A. S., Charlebois, P., Stein, B., Scheede-Bergdahl, C., Awasthi, R., … Carli, F. (2019). The impact of improved functional capacity before surgery on postoperative complications: A study in colorectal cancer. Acta Oncologica, 58(5), 573-578. 14. Sánchez-Torralvo, F. J., González-Poveda, I., García-Olivares, M., Porras, N., Gonzalo-Marín, M., Tapia, M. J., … Olveira, G. (2022). Poor physical performance is associated with postoperative complications and mortality in preoperative patients with colorectal cancer. Nutrients, 14(7), 1484.
- Results publication1. Mao, J. X., Gao, R., Wang, Y., Yan, X. B., & Wang, H. H. (2025). Surgical treatment of colorectal cancer: A multidimensional review. World Journal of Gastrointestinal Surgery, 17(8), 107785. 2. Pickhardt, P. J., Kim, D. H., Pooler, B. D., Hinshaw, J. L., Barlow, D., & Mccoy, A. (2011). Colorectal cancer: CT colonography and colonoscopy for detection-Systematic review and meta-analysis. Radiology, 259(2), 393-405. 3. Toma, M., Beluşică, L., Stavarachi, M., Apostol, P., Spandole, S., Radu, I., & Cimponeriu, D. (2012). Rating the environmental and genetic risk factors for colorectal cancer. Journal of Medicine and Life, 5(Special Issue), 152-159. 4. Carr, P. R., Weigl, K., Jansen, L., Walter, V., Erben, V., Chang-Claude, J., Brenner, H., & Hoffmeister, M. (2018). Healthy lifestyle factors associated with lower risk of colorectal cancer irrespective of genetic risk. Gastroenterology, 155(6), 1805-1815.e5. 5. de Nes, L. C. F. (2025). Assessment and improvement of quality of care in colorectal cancer surgery (Doctoral dissertation). 6. Tomruk, M., Karadibak, D., Yavuzşen, T., & Akman, T. (2015). Predictors of functional capacity in colorectal cancer patients. Supportive Care in Cancer, 23(9), 2747-2754. 7. van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., … Slooter, G. (2019). Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: The first international randomized controlled trial for multimodal prehabilitation. BMC Cancer, 19(1), 98. 8. Whelan, M., van Aswegen, H., Roos, R., Fabian, J., & Bebington, B. (2021). Preoperative physical activity and functional performance levels are predictors of acute postoperative outcomes in a private South African colorectal cancer cohort. South African Journal of Physiotherapy, 77(1), 1526.
- 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.
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 and Respiratory Function, run by Inonu University at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Müşerref Ebru YALÇIN, PhD (+905557136666, M.ebrusen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) (time frame: 2 years). 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 NCT07523919, which also lists 2 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 13 Apr 2026.