NCT07108348 ADAR1 Expression Level in Rectal Cancer
| NCT ID | NCT07108348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Necmettin Erbakan University |
| Condition | Rectum Cancer, Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Total neoadjuvant therapy (TNT) is currently the standard treatment for locally/locally advanced rectal cancer due to better response and fewer distant metastases. In TNT, sequential chemotherapy (CT) and chemoradiotherapy (CRT) are planned and depending on the treatment response, either surgery is performed or a watch and wait approach is applied. Depending on tumor localization and patient performance status, CT is planned as induction or consolidation. Most of the time, mFOLFOX6 and CAPOX are preferred as CT regimen. In proximal rectal cancer, surgery can be performed without CRT and only after CT. In locally/locally advanced rectal cancer, the aim is to avoid surgery as much as possible or to perform sphincter-sparing surgery if possible. Colonoscopy and pelvic MR at the time of diagnosis are the most important steps in staging, treatment selection and decision making. These two diagnostic methods should be repeated especially for watch and wait decision and for response evaluation after TNT. ADAR 1 (Adenosine deaminase acting on RNA1) is an RNA editing enzyme that catalyzes the deamination of adenosine to inosine (A-to-I), a dynamic modification that can lead to a diverse transcriptome in a combinatorial manner. A defect in ADAR1-mediated RNA modification results in abnormal regulation of substrates that can affect phenotypic changes in cancer. This phenomenon of over-regulation is seen in many cancers such as colon, liver, lung, breast and esophageal cancers and in many cases promotes tumor progression. In studies, increased ADAR1 expression has been associated with lower survival and worse prognosis, especially in metastatic colon and gastric cancer. ADAR1 is also predicted to increase proliferation through both the AKT pathway and the mTOR pathway and therefore may be targeted in the near future. ADAR1 expression is monitored by RNA-based real time PCR. In order to demonstrate increased expression, biopsies should be taken from the malignant tissue and the intact tissue of the patient and the biopsy should be stored under -80 C conditions immediately after biopsy to prevent RNA degradation. The tissue will not come into contact with nitrogen or formaldehyde. In this study, sufficient biopsies from cancerous and intact tissue will be taken from patients with suspected rectal cancer, confirmed by pelvic MRI and consent for participation in the study, and fresh tissue will be stored at -80 C in the genetics laboratory. After the TNT plan is made by the investigators and the treatment is completed, both pelvic MRI and control rectoscopy will be performed for preoperative evaluation. Again, biopsies will be taken from diseased and healthy tissue and ADAR1 expression will be evaluated. The study is planned to include 50 participants and a period of one year is foreseen for tissue procurement/storage. The investigators' aim in this study will be to determine whether ADAR1 expression level changes after TNT, whether this predicts clinical and pathological response, whether responses change according to the selected CT, whether there is a difference between CT induction-consolidation/RT short or long course, and the relationship between tumor DNA mismatch repair enzyme status and ADAR1 level. The investigators primary endpoint will be the effect of the change in ADAR1 expression level on the response after TNT (ORR). Secondary endpoints will be quality of life, recurrence-free survival (RFS) and overall survival (OS).
Eligibility Criteria
Inclusion Criteria: * Histological and staging diagnosis of local/locally advanced rectal cancer * ECOG performance score between 0 and 2 * No contraindications for chemotherapy (CT) and/or radiotherapy (RT) Exclusion Criteria: * Those diagnosed with metastatic rectal cancer * Those suspected of having rectal cancer or patients with a diagnosis of a second primary cancer * Those who have not signed the informed consent form * Those with contraindications for chemotherapy (CT) and/or radiation therapy (RT)
Contact & Investigator
Mehmet Artaç, MD
STUDY DIRECTOR
Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology
Frequently Asked Questions
Who can join the NCT07108348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Rectum Cancer, Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07108348 currently recruiting?
Yes, NCT07108348 is actively recruiting participants. Contact the research team at mdahmetoruc@gmail.com for enrollment information.
Where is the NCT07108348 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT07108348 clinical trial?
NCT07108348 is sponsored by Necmettin Erbakan University. The principal investigator is Mehmet Artaç, MD at Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology. The trial plans to enroll 50 participants.
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