RecruitingNAINTERVENTIONAL

Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study

This research aims to find better ways to predict how well chemotherapy will work for people with stomach (gastric) and oesophageal junction (cardia) cancer. Sometimes, standard chemotherapy doesn't work well for certain types of these cancers, and giving it can even delay surgery, which isn't good. The study will examine tissue samples taken from biopsies to look for special 'markers' – like tiny biological signals – that can tell doctors which patients are likely to benefit most from chemotherapy, either before or after their operation. By understanding these markers, the hope is to help doctors make more informed decisions about treatment plans, ensuring patients get the most effective care without unnecessary delays.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Strasbourg, France

Enrolment target

Start

01 May 2016

Estimated completion

01 Aug 2029

Gastric and Cardia Adenocarcinomas

What is this study about?

When someone has stomach (gastric) or oesophageal junction (cardia) cancer, chemotherapy is often a key part of their treatment. This can be given before surgery to shrink the tumour, or after surgery to kill any remaining cancer cells. However, doctors know that for some types of these cancers, chemotherapy doesn't always work as well as hoped, or it might not work at all. In these situations, giving chemotherapy could actually delay surgery, which many experts believe is not helpful for the patient.

This study is trying to solve this problem. Researchers want to find new ways to predict, *before* someone starts chemotherapy, whether it will be effective for their specific type of cancer. They'll do this by looking closely at small tissue samples, called biopsies, taken from the tumour. They are searching for special 'markers' within these samples – these are like tiny biological signals or features – that can tell them if the cancer is likely to respond well, or poorly, to the chemotherapy treatments doctors usually give.

The main goal is to identify these important markers. If successful, this research could help doctors make much more informed decisions. They could then choose the best treatment plan for each individual patient from the start, knowing who is most likely to benefit from chemotherapy before surgery, after surgery, or perhaps even who might be better off going straight to surgery without chemotherapy first. This could lead to more effective treatment and better outcomes for patients with these types of cancer.

Key takeaways

Aims to predict chemotherapy effectiveness for stomach/cardia cancer.
Uses existing biopsy samples; no new treatments or extra tests involved.
Could help doctors choose the best treatment plan for future patients.
Looks at 'markers' in cancer cells for better treatment decisions.
Involves patients aged 18 and over with gastric or cardia adenocarcinoma.

Who may be eligible?

To join this study, you would need to have been diagnosed with stomach (gastric) cancer in any part of your stomach, or cancer where the food pipe meets the stomach (cardia cancer). You must be at least 18 years old. Importantly, you would need to be well enough to take part, as measured by a standard health check (your doctor can explain what a WHO Index score of 3 means).

Before taking part, you would also need to fully understand what the study involves and sign a consent form, showing you agree to participate. This ensures you are comfortable and informed about every step.

There are also reasons why you might not be able to join. For example, if you are currently being treated for another type of cancer with chemotherapy, or if you are pregnant or breastfeeding. Also, if understanding all the study information is difficult for you, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with stomach (gastric) or cardia cancer?
Are you 18 years old or older?
Are you generally well enough to manage your usual daily activities?
Are you *not* currently pregnant or breastfeeding?
Are you *not* currently receiving chemotherapy for another type of cancer?

Answer every question to see your result.

What does participation involve?

This study is a bit different because it primarily involves looking at samples that have already been collected as part of your standard medical care, such as biopsies taken when your cancer was first diagnosed. It will also involve looking at information already gathered about your health and treatment.

If you qualify and agree to take part, you might be asked to fill out a questionnaire about your lifestyle. The researchers will also compare your treatment journey and how you responded to chemotherapy with the findings from the tissue samples. They will also look at how you're doing over time, specifically for up to 5 years after your diagnosis, to understand how the markers they find relate to your recovery and quality of life.

This study doesn't involve new medicines or extra procedures you wouldn't already be having as part of your normal cancer treatment.

Potential risks and benefits

The main benefit of taking part in this study is that it doesn't involve any new or experimental treatments or procedures. Researchers will be using samples and information that have already been collected as part of your usual care. While there are no direct benefits to you personally from taking part, your contribution will be incredibly valuable. The information gathered could help doctors in the future make better treatment choices for other people with stomach and cardia cancers. There are no significant risks because no new treatments or procedures are involved. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospital, Strasbourg, france
Verified postcode
Strasbourg, France· Recruiting

Common questions

What kind of cancer is this study about?

This study focuses on stomach (gastric) cancer and cancer where the food pipe meets the stomach (cardia adenocarcinoma).

Will I have to take new medicine or get extra tests?

No, this study mainly uses existing biopsy samples and health information from your normal care. You won't take new medicines or have extra tests just for the study.

Why is this research important?

It aims to help doctors predict which chemotherapy will work best for each patient, so they can get the right treatment at the right time and avoid delays to surgery.

Who can join the study?

Adults (18+) with stomach or cardia cancer who are well enough and understand and agree to take part. Pregnant/breastfeeding women or those with other cancers being treated with chemotherapy cannot join.

What happens with information about my lifestyle?

You might be asked to complete a questionnaire about your lifestyle to see if it affects how well chemotherapy works.

How to find out more

Benoît ROMAIN, MD

benoit.romain@chru-strasbourg.fr 03/88/12/72/43 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.