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Should leftover rectal lesions be removed or watched? small trial aims to find out.

NCT ID NCT07192627

Knowledge-focused Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at people with rectal cancer who have small leftover spots after chemoradiotherapy. One group will have these spots removed with a scope, while the other group will just be watched closely. The goal is to see which approach leads to better cancer control after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endoscopic mucosal dissection (procedure)
What this could lead to
If successful, this could clarify whether removing small leftover lesions after chemoradiotherapy improves cancer control compared to simply watching them.
What could go wrong
This is a very small, early-phase study with only 20 participants, so results may not apply broadly. The best approach for these lesions remains uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who completed locoregional chemoradiotherapy with organ preservation intent will be prospectively enrolled. Post-CRT restaging at 8-12 weeks will be discussed at MDT. Patients with a small residual mucosal/submucosal lesion amenable to en-bloc endoscopic resection will be offered ESD (CRT→ESD). Patients with clinical/radiologic complete or near-complete response and no endoscopically resectable residual lesion will be managed with structured surveillance (CRT→Follow-up)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients with rectal adenocarcinoma who underwent full course locoregional chemoradiotherapy with organ-preservation intent. Post-CRT assessment showing either: A. Small residual mucosal/submucosal lesion amenable to en-bloc ESD (CRT→ESD), OR B. Clinical/radiologic near-complete/complete response and decision to observe (CRT→Follow-up). Exclusion Criteria: * \- Evidence of distant metastasis at post-CRT restaging. * Lesions unsuitable for endoscopic resection (circumferential, deeply invasive on EUS/MRI). * Patients who had immediate TME after CRT for other reasons. * Unfit for endoscopy or follow-up.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assiut University

    Asyut, 71515, Egypt

More trials for these conditions

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