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NCT Number: NCT07378631

Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury

This is a prospective, observational study aimed at exploring the associations between the clinical subtypes of radiation rectal injury and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. During the study period, researchers will not intervene in clinical treatment decisions but will only collect patient clinical information, intestinal endoscopy/imaging/pathological data, test results, and follow-up data. The study results will fill the evidence gap in this field, advance the diagnosis and treatment of radiation-induced rectal injury, and provide scientific support for improving the prognosis of similar patients.

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Key information

Conditions

Radiotherapy Radiation Proctitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Qiyuan Qin, M.D.

CONTACT

[email protected]

86-20-38254052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years;
  • Diagnosed with radiation rectal injury.

Exclusion criteria

  • Ongoing cancer therapy;
  • Tumor recurrence or metastasis.

Treatment and study plan

Primary outcomes

  1. Association between Clinical Classification and Clinical Outcomes

    Time frame: 6 months

    To investigate the association between clinical subtypes and outcomes, the primary outcome was assessed as complete remission of their primary symptom, while the measure was identified as the remission rate.

Secondary outcomes

  1. Predictive Accuracy of Endoscopic Characteristics for Clinical Subtyping

    Time frame: 6 months

    Using prospectively collected endoscopic data, the investigators will assess the association between specific endoscopic features and the data-driven clinical subtypes. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification.

  2. Predictive Accuracy of Imaging Evaluation for Clinical Subtyping

    Time frame: 6 months

    Using prospectively collected endoscopic data, the investigators will assess the association between features of MRI/CT and the data-driven clinical subtypes. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiyuan Qin, M.D.

CONTACT

[email protected]

86-13580359171

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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